annual report - kidney health australia · 2016-08-15 · annual report the australasian kidney...

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2015 Annual ReportThe Australasian Kidney Trials Network (AKTN) is a collaborative research group with a commitment to conducting and supporting high-quality, investigator-initiated clinical trials to benefit patients with kidney disease.

The AKTN operates within the UQ School of Medicine’s Centre for Kidney Disease Research (CKDR).

2 AKTN | Annual Report 2016

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This year has been an exciting year for the Australasian Kidney Trials Network (AKTN) with 2015 marking our 10-year Anniversary, and our 10th year of trial conduct just around the corner (2016). To begin with, we have had some fantastic progress with our trials. The FAVOURED study primary outcomes were presented at the American Society of Nephrology (ASN) and numerous secondary outcome papers for the HERO and HONEYPOT trials were published.

Our special interest groups have also increased participation and productivity. We would like to thank each and every one of the members for their ongoing involvement and dedication. There have been some innovative and exciting trial ideas originating from these groups, with two studies progressing to planned submissions to the NHMRC funding rounds in early 2016.

The AKTN also had NHMRC Program Grant success in 2015. The Better Evidence And Translation in Chronic Kidney Disease (BEAT-CKD ) Program led by Professor Jonathan Craig, and supported by Professor David Johnson, Professor Jeremy Chapman, Associate Professor Carmel Hawley and Professor Stephen McDonald has secured funding for the AKTN for the next five years.

The aim of the AKTN is to improve the lives of people living with chronic kidney disease (CKD) in Australia and globally by generating reliable evidence to inform healthcare decisions made by clinicians, policy makers, and patients. The BEAT-CKD Program is the vehicle by which this aim will be furthered. The scope of the Program is broad ranging, covering the entire spectrum of CKD from early stage through to people on Renal Replacement Therapy (RRT), but focused on clinical research methods. The value added by the BEAT-CKD Program is a coherent, coordinated, patient-prioritised approach to identifying interventions most likely to benefit people with CKD across all

platforms, and encompassing the entire ‘discovery to implementation’ pathway. BEAT-CKD funding has ensured the AKTN can continue to build on its past successes and advance its important contribution to providing evidenced based treatment options for people living with kidney disease.

This year ACTA (The Australian Clinical Trials Alliance; www.clinicaltrialsalliance.org.au) held their inaugural International Clinical Trials Symposium in Sydney. Members of the AKTN Operations Secretariat played an important role in the main program including presentations on the opportunities and challenges associated with large pragmatic trials (Vlado Perkovic), and the move to registry randomised trials as the future of clinical trial research (Carmel Hawley).

We would like to thank our Advisory Board led by Professor David Harris for their ongoing support and contribution in providing strategic direction to the Network. We would also like to thank the excellent support that we have had from the Data & Safety Monitoring Boards as well as the invaluable input from our Scientific Committee in guiding the AKTN’s research agenda. Finally we would like to thank our Executive Operations Secretariat members as well as the AKTN operations team for their unwavering support and contribution to the AKTN’s operational matters in what has been a year of rapid expansion in terms of research and publication output.

Thank you to all our supporters and partners including hospital site staff, consumers and the broader kidney care community. We look forward to even greater opportunities for expanding the AKTN’s activities in 2016, and we couldn’t do it without you!

www.aktn.org.au

Executive Message

Associate Professor Carmel Hawley Chair, AKTN Operations Secretariat

Professor Neil BoudvilleChair, AKTN Scientific Committee

AKTN | Annual Report 2015

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Contents

Executive Message 3

About Us 6The AKTN Team 7

Collaboration 8Advisory Board 8Executive Operations Secretariat 9Scientific Committee 10Trial Steering Committees 11Working Groups 12Data & Safety Monitoring Boards 13

Kidney Trials 14Trials in Development 14Currently Recruiting 16Completed Recruitment 18

Publications 20General 20Trial Specific 21

Financial Overview 22

The AKTN - A Global Collaboration 24Partners/Sponsors 25Contact Us 25


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The Operations Secretariat of the Australasian Kidney Trials Network (AKTN) is a centre within the School of Medicine's Centre for Kidney Disease Research (CKDR) at the University of Queensland, and is located at the Princess Alexandra Hospital campus, Woolloongabba.

Established in 2004, the AKTN was developed to deliver high quality clinical trials to improve the health and wellbeing of people with kidney disease. This collaborative research group engages with consumers of research, nephrologists, renal and research nurses, epidemiologists, biostatisticians, and other allied health professionals to design, conduct and support clinical trials focussed on improving appropriate patient-centred outcomes.

The AKTN is run by a dedicated team of clinicians, researchers, statisticians, trial managers and support officers who have a passion for clinical trials and helping those with chronic kidney disease improve their quality of life.

For more please visit www.aktn.org.au


7AKTN | Annual Report 2015

Executive Operations SecretariatCarmel Hawley (Chair)David Johnson (Deputy Chair)Neil BoudvilleAlan CassVlado PerkovicMeg Jardine

Clinical TrialistsSunil BadveMagid FahimYeoungjee Cho

Head, Biostatistics & Data ManagementElaine Pascoe

BiostatisticianDarsy Darssan

Clinical Operations ManagerAlicia Morrish

Clinical Project ManagersDonna ReidlingerPeta-Anne Paul-Brent

Data ManagerLiza Vergara

Clinical Research AssociatesAndrea ValksLaura Robison

Executive Support OfficerJosephine Parry

Research AssistantJean Helyar

The AKTN Team

AKTN team members gathering in the office for a farewell. From left to right: Laura Robison, Alicia Morrish, Liza Vergara, Donna Reidlinger, Peta-Anne Paul-Brent and Elaine Pascoe.

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Collaboration

The AKTN collaborates extensively in order to ensure trials conform to international safety standards as well as having scientific integrity. The following boards/committees have been established with the aim of assisting the Network in designing, conducting and monitoring trials.

• Advisory Board• Executive Operations Secretariat • Scientific Committee• Trial Steering Committees• Working Groups• Data & Safety Monitoring Boards

If you are interested in collaborating with us, please contact our office on +61 7 3176 7716 or email us at [email protected]. For more information visit www.aktn.org.au.


Members David Harris (Chair) Mark Bowles Val Gebski Stephen Nicholls Ann Bonner

Advisory Board

The Advisory Board is required to assess the overall management of the Network, including its financial and organisational competence, strategic direction and performance. The inaugural chair is Professor David Harris from the department of Renal Medicine at Westmead Hospital. The board meet at least once annually at a face-to-face meeting organised by the AKTN Operations Secreteriat. The following is a list of current members which includes a Nephrologist with extensive clinical research experience, an expert in financial/business management, a statistician with specialist clinical trial expertise and an academic research nurse.


Advisory Board

Executive Operations Secretariat

Members Carmel Hawley (Chair; AKTN Chair)David Johnson (AKTN Deputy Chair)Vlado Perkovic Neil Boudville Meg Jardine Magid Fahim Yeoungjee Cho Elaine Pascoe Alicia MorrishDonna ReidlingerPeta-Anne Paul-Brent

The Queensland-based Executive Operations Secretariat (EOS) is the hub of the Australasian Kidney Trials Network. It is from the Brisbane office that the AKTN multi-centre clinical trials are coorindated and educational opportunities managed. The Operations Secretariat is the "engine room" of the organisation being responsible for the appropriate data, human resources and financial management operations of the network. The EOS consists of the following members.


Scientific Committee

MembersNeil Boudville (Chair)Meg Jardine (Deputy Chair)Fabian Marden (Consumer Rep.)Carmel Hawley (AKTN EOS Chair)David Johnson (AKTN EOS Deputy Chair)Elaine Pascoe (AKTN)Vlado Perkovic Chen Au Peh Jonathan Craig Josephine Chow Katrina Campbell Martin Gallagher Matthew Jose

Matthew Roberts Nigel Toussaint Rob MacGinley Rob Walker Solomon Cohney Stephen McDonald Suetonia Palmer Wai LimSunil Badve (AKTN; ex-officio) Magid Fahim (AKTN; ex-offcio) Yeoungjee Cho (AKTN; ex-officio) Donna Reidlinger (AKTN; ex-officio)Alicia Morrish (AKTN; ex-officio)

The role of the Scientific Committee is to provide scientific leadership to the AKTN by providing peer review of proposals submitted to the AKTN with regard to scientific merit, feasibility and clinical relevance, prioritisation of clinical trials and other network activity, voting on the AKTN's involvement in individual trials, and advising on audience and content of educational sessions. The following are the terms of reference for the committee.

• Provide an evaluation of clinical trials proposed for coordination/facilitation to ensure they are of scientific value, statistical and logistical feasibility and conform to ethical guidelines

• Be involved as a Chair or Member of a Working Group• Approve and implement trial selection criteria and/or scientific review mechanisms• Decide by vote on whether to co-ordinate or facilitate proposed trials• Provide advice on content and structure of educational and promotional activities• Receive reports on progress from principal investigators• Report annually to the Advisory Board


Scientific Committee Trial Steering Committees

HONEYPOT TrialDavid Johnson (Chair)Alan CassCarmel HawleyJanak De ZoyzaPaul SnellingSteven McTaggartGeoffrey PlayfordCarolyn ClarkCharles ThompsonLiza VergaraElaine Beller

FAVOURED TrialAshley Irish (Chair) David VossAmanda RobertsonAlan CassCarmel HawleyVlado PerkovicSharan DograTrevor MoriKevan PolkinghornePeter KerrElvie HaluszkiewiczDavid GraceyAmanda MatherStephen McDonaldHooi Lai SeongColin HutchinsonChris McIntyrePeta-Anne Paul-BrentMichael Watson

Alicia MorrishCharles Thompson

HERO TrialDavid Johnson (Chair)Alan CassVlado PerkovicCarmel HawleyStephen McDonaldRowan WalkerRob FassettPaolo FerrariGenie PedagogosCarl KirkpatrickRichard PoonEmanuel D'AlmeidaAlicia MorrishSunil BadveCharles ThompsonDonna ReidlingerLiza Vergara

PEXIVAS TrialChen Au Peh (Chair)Rendall FaullJanak de ZoysaPeter KerrRobyn LanghamGiles WaltersVlado PerkovicSunil BadveAlicia MorrishDonna Reidlinger

Peta-Anne Paul-BrentAndrea ValksBLOCADE TrialMatthew Roberts (Chair)Alan CassCarmel HawleyHenry KrumVlado PerkovicAmit GangAndrew TonkinFrank IerinoNikky IsbelHelen PilmoreElaine PascoeLiza Vergara

IMPROVE-CKD TrialEugenie Pedagogos (Co-Chair)Nigel Toussaint (Co-Chair)Randall FaullGrahame ElderCarol PollockKen LauKevan PolkinghorneNeil BoudvillePeter KerrRob WalkerSteve HoltKatrina CampbellAngela Wang

Carmel HawleyVlado PerkovicSunil BadveAlicia MorrishElaine PascoeCharles ThompsonAndrea Valks

CKD-FIX TrialDavid Johnson (Chair)Sunil BadveNeil BoudvilleFiona BrownAlan CassPhilip ClarkeNicola DalbethRic DayJanak de ZoysaBettina DouglasRobert FassettRandall FaullDavid HarrisCarmel HawleyGraham JonesJohn KanellisSuetonia PalmerElaine PascoeVlado PerkovicGopala RanganPeta-Anne Paul-BrentRob WalkerGiles WalkersLaura Robison

For AKTN-coordinated trials, the role of the Trial Steering Committee (TSC) is to develop the protocol, provide input into the development of trial resources, and monitor the conduct of the trial via feedback from the Trial Clinical Research Associate (CRA) or Site Investigator Committee. The aim is to ensure participant safety, scientific rigor and data validity. The following is a list of members for each committee (since inception).

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Working Groups


AKI Working GroupMartin Gallagher (Chair) Alan CassRinaldo BellomoRobyn LanghamShay McGuinnessVincent DintiniZoltan Endre

CKD-GN Working GroupNigel Toussaint (Chair)Alan ParnhamChen Au PehChris HoodCarmel HawleyGiles WaltersJean TanJoshua KausmanKatrina CampbellLisa JeffsSuet-Wan ChoySunil BadveVlado Perkovic

HD Working GroupMeg Jardine (Chair)Matthew RobertsAmanda MatherCarmel HawleyColin HutchinsonFabian MarsdenJoanna DunlopKevan PolkinghorneNicholas GraySamantha Hand

Methods Working GroupElaine Pascoe (Chair)Jonathon CraigMagid FahimPhil ClaytonSuetonia Palmer

PD Working GroupMatthew Jose (Chair)Carmel HawleyDavid Johnson

Jeff WongJo-Anne MoodieJosephine ChowLouis HuangNeil BoudvilleRob MacGinleyYeoungjee Cho

Transplant Working GroupWai Lim (Chair)Allison TongAron ChakeraGermaine WongJohn KanellisKatherine BaracloughMichael CollinsNeil BoudvillePhil ClaytonRob CarrollRoss FrancisSolomon CohneySteve McTaggart

The AKTN Working Groups were originally borne out of the Scientific Committee and are responsible for: generating trial ideas, providing scientific evaluation of proposals submitted to the network for peer review, developing AKTN research priorities, liaising with the Operations Secretariat to provide advice and assistance on trial protocol development, and promotion and education on specialty-specific trials across ANZ. The following is a list of our working groups and current members.

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Working Groups


Data & Safety Monitoring Boards (DSMB)

Current DSMB

IMPROVE-CKD and CKD-FIX TrialsMembers Bruce Neal (Chair)Andrew Forbes David Wheeler Christoph Wanner

Past DSMB

HERO, FAVOURED and HONEYPOT TrialsMembers Andrew Tonkin (Chair) Andrew Forbes Adeera Levin David Wheeler

BLOCADE TrialMembers Adeera Levin (Chair)Andrew Martin David Hare David Wheeler

A Data & Safety Monitoring Board (DSMB) is an independent body of clinicians, statisticians, and individuals from other disciplines whose task is to review accumulating trial data and make recommendations to the Trial Steering Committee concerning the conduct of the trial and whether the trial should continue in its current form. The primary objective of a DSMB is to ensure that the trial remains appropriate and safe for individuals who have been, or are still to be, enrolled. Other responsibilities include monitoring trial progress and overall quality of trial conduct.

The AKTN currently has one DSMB which is responsible for monitoring accumulating data for the IMPROVE-CKD and CKD-FIX trials. The DSMB met in March 2015 and recommended both trials continue under their current protocols.

Members of current and past DSMBs and the trials they monitored are as follows.


Kidney Trials

This year was a very busy year for the AKTN. The Working Groups have worked hard to bring us great trial ideas which have translated to four trials that are now in development. We are currently recruiting for four trials and are celebrating the completion of another four trials. Please see below for a summary.

If you are interested in joining one of our trials, please contact our office on +61 7 3176 7716 or email us at [email protected]. For more information visit www.aktn.org.au/trials.

Trials in Development

Trials in Development• REMOVAL-HD• RESOLVE• BEST-Fluids• TEACH-PD

Currently Recruiting• PEXIVAS• IMPROVE -CKD• CKD-FIX• PDOPPS

Completed Recruitment• HONEYPOT• HERO• BLOCADE• FAVOURED

REMOVAL-HD Principal Investigator: Dr Colin Hutchison

A tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients

The REMOVAL-HD Study includes haemodialysis patients with AV fistula or graft and aims to use Theranova dialysers to increase the removal of the larger middle-molecules without significant decrease in serum albumin. The study is a single armed, open label, pivotal device trial and the primary outcome is change in pre-dialysis concentration of serum albumin between baseline and six months. The study has an Investigator Initiated Research (IIR) Grant of US$250,000 provided by Baxter Healthcare Corporation and the recruitment target is 85 patients in eight sites in Australia and New Zealand.


Trials in Development

RESOLVE Study Principal Investigator: A/Prof Meg Jardine

Randomised Evaluation of SOdium dialysate Levels on Vascular Events: A cluster Clinical Trial

In the RESOLVE study, haemodialysis units in Australia, New Zealand, China, India and other interested countries will be randomised for all patients to receive one of two sodium dialysate levels (137mmol/L or 140mmol/L). Incidents of major cardiovascular events are monitored (i.e. hospitalised myocardial infarction, hospitalised stroke, coronary artery or cerebrovascular revascularisation and all-cause death) with trial data collected using existing registries (i.e. ANZDATA in Australia and New Zealand). An application for New Zealand HRC project funding has been submitted and Australian NHMRC project funding will be applied for in 2016. International Collaboration is led by the George Institute, Sydney and Australian collaboration is led by the Australasian Kidney Trials Network.

BEST-Fluids Study Principal Investigator: Dr Michael Collins

The effect of a low-chloride balanced crystalloid solution compared with 0.9% saline on kidney transplant graft function; a multi-centre phase III randomised controlled trial

Adults and children who are admitted for deceased donor kidney transplant will be given either Plasma-Lyte© 148 or a normal Saline solution (0.9% sodium chloride) and the primary outcome is a composite of the duration of Delayed Graft Function (requirement of dialysis) and the rate of recovery of draft function (creatine reduction ratio). The target recruitment for this study is 574 participants and an NHMRC grant will be submitted in 2016.

TEACH-PD Study Principal Investigators: A/Prof Josephine Chow and Prof Neil Boudville

Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes

PD nurse trainers will be placed into an open, cluster-randomised controlled trial of a standardised education program. The study seeks to measure changes in a composite of all PD-related infections (including exit-site infections, technique failure, tunnel infection or peritonitis). There are two stages to the trial: a pilot study involving two sites and a full trial with site number to be determined. Baxter Healthcare Corporation have given $56,464 towards the study and Kidney Health Australia via the AKTN have contributed $10,000. Applications to the BEAT-CKD Program grant, NSW TRGS and ISPD have also been made.

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Currently Recruiting

The PEXIVAS Trial: Plasma EXchange and glucocorticoids In anti-neutrophil cytoplasm antibody associated systemic VASculitis

Principal Investigator: Dr Chen Au PehProject Officer: Andrea Valks (AKTN)Trial Number: EUDRACT 2009-013220-24

Population: Patients with confirmed severe ANCA-associated vasculitis plus new or relapsing Wegener’s granulomatosis or microscopic polyangitis.Intervention: PLEX vs no PLEX in combination with standard dose vs reduced dose glucocorticoidsFollow-up: 1-7 yearsPrimary outcome: Composite of all-cause mortality or end-stage kidney diseaseStatus: Australian & New Zealand and worldwide sites currently recruitingRecruitment end date: 30 November 2016Follow-up end date: December 2017Recruitment: 100/100 (worldwide recruitment: end of 2015 - 606/700; 87%)

The IMPROVE Trial: IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease

Principal Investigator: Dr Nigel Toussaint and Dr Eugenie PedagogosProject Officer: Andrea Valks (AKTN)Trial Number: AKTN 10.01

Population: CKD stage 3b/4 patients Intervention: Lanthanum carbonate (1500-3000mg) vs placebo, dailyFollow-up: 24 monthsPrimary outcome: Arterial compliance (PWV)Status: Australian & New Zealand sites currently recruiting; and sites in Malaysia were seeking approval for participationRecruitment end date: 31 December 2016Follow-up end date: December 2018Recruitment: 175/300 [58%]


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Currently Recruiting

The CKD-FIX Study: a randomised Controlled trial of slowing of Kidney Disease progression From the Inhibition of Xanthine oxidase

Principal Investigator: Professor David JohnsonClinical Project Manager: Laura Robison (AKTN)Trial Number: AKTN 10.02

Population: Adults with CKD stage 3/4 and progression of CKD in past 12 monthsIntervention: Allopurinol (100-300mg) vs placebo, dailyFollow-up: 24 monthsPrimary outcome: Change in eGFRStatus: Australian and New Zealand sites currently recruitingRecruitment end date: 31 December 2016Follow-up end date: December 2018Recruitment: 188/620 [30%]

The PDOPPS Study: The Australian Peritoneal Dialysis Outcomes and Practice Patterns Study

Principal Investigator: Professor David JohnsonClinical Project Manager: Laura Robison (AKTN)Trial Number: AKTN 13.01

Population: Adults receiving chronic maintenance PDIntervention: N/A – observational studyFollow-up: 3 yearsPrimary aim: To understand the impact of modifiable practices in the management of PD patients on the risk of all-cause peritoneal dialysis technique failure.Status: Australian recruitment commenced November 2014Recruitment end date: 31 December 2016Follow-up end date: 31 December 2016Recruitment: 277/640 [43%]


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Completed Recruitment


The HONEYPOT Trial: HOney versus Nasal Eradication of staphYlococci for the Prevention Of Tenckhoff infections in PD

Principal Investigator: Professor David JohnsonClinical Research Associate: Liza Vergara (AKTN)Trial Number: AKTN 06.02

Population: Peritoneal Dialysis patientsFinal recruitment number: 371 (target of 370)Intervention: MedihoneyTM applied to exit site twice daily versus standard practice for 24 monthsPrimary outcome: Time to event: exit-site infection, tunnel infection, peritonitis

The HERO Trial: Handling Erythropoietin Resistance with Oxpentifylline

Principal Investigator: Professor David JohnsonClinical Research Associate: Alicia Morrish (AKTN)Trial Number: AKTN 06.03

Population: Stage 4/5 CKD patients with moderate to high resistance to ESAFinal recruitment number: 53 (target of 110)Intervention: 400mg Oxpentifylline versus placebo, daily for four monthsPrimary outcome: ESA Resistance index at four months

Results: The HONEYPOT trial showed that topical honey is not more effective than standard practice in the prevention of catheter-associated infections in peritoneal dialysis patients. Results of the study have been published in the Lancet Infectious Diseases and Peritoneal Dialysis International.

Results: The HERO trial found that Oxpentifylline did not significantly reduce ESA resistance, but did safely increase haemoglobin levels despite a non-specific reduction in ESA dose. Oxypentifylline should be considered a treatment option for patients with ESA-resistant anaemia. Results of the study have been published in Nephrology, the Canadian Journal of Kidney Health and Disease, REDOX Report and Am J Kidney Dis.

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Completed Recruitment


The BLOCADE Trial: Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study

Principal Investigator: Dr Matthew RobertsClinical Research Associate: Liza Vergara (AKTN)Trial Number: AKTN 08.01

Population: Dialysis patients aged over 50 years or under 18 years with a history of diabetes, MI, peripheral arterial disease or strokeFinal recruitment number: 72 (target of 150)Intervention: Carvedilol (6.25-25mg) versus placebo, daily for 12 monthsPrimary outcome: Safety and tolerability of intervention as well as feasibility of recruitment

The FAVOURED Trial: Omega-3 Fatty Acids (Fish Oils) and Asprin in Vascular access OUtcomes in REnal Disease

Principal Investigator: Dr Ashely IrishClinical Research Associate: Peta-Anne Paul-Brent (AKTN)

Population: Stage 4/5 CKD patients undergoing or planning to undergo Haemodialysis with planned de novo AVFFinal recruitment number: 567 (target of 650)Intervention: Aspirin (100mg) and/or Omega-3 (4000mg) fatty acids versus placebo, daily for 12 weeksPrimary outcome: AVF Access Failure rate over 12 months

Results: The BLOCADE trial demonstrated the need for a very large pool of patients from which to recruit with greater international collaboration required. Results of the study have been published in the American Journal of Kidney Disease, and Nephrology.

Results: The FAVOURED study is unable to recommend the use of fish oil or aspirin for the prevention of AVF failure. Additional studies and strategies to reduce the current unacceptably high AVF failure rate are urgently required. The results of the study have been presented at the ASN Kidney Week in November 2015 and the final results paper will be submitted to JAMA internal medicine in 2016.


Tong A, Crowe S, Chando S, Cass A, Chadban SJ, Chapman JR, Gallagher M, Hawley CM, Hill S, Howard K, Johnson DW, Kerr PG, McKenzie A, Parker D, Perkovic V, Polkinghorne KR, Pollock C, Strippoli GF, Tugwell P, Walker RG, Webster AC, Wong G, Craig JC. Research Priorities in CKD: Report of a National Workshop Conducted in Australia. Am J Kidney Dis. 2015 May 2. pii: S0272-6386(15)00593-4. doi: 10.1053/j.ajkd.2015.02.341. [Epub ahead of print] PMID: 25943716

Campbell DJ, Brown FG, Craig JC, Gallagher MP, Johnson DW, Kirkland GS, Kumar SK, Lim WH, Ranganathan D, Saweirs W, Sud K, Toussaint ND, Walker RG, Williams LA, Yehia M, Mudge DW. Assessment of current practice and barriers to antimicrobial prophylaxis in peritoneal dialysis patients. PMID: 25906780

Rossi M, Johnson DW, Campbell KL. The Kidney-Gut Axis: Implications for Nutrition Care. J Ren Nutr. 2015 Mar 23. pii: S1051-2276(15)00019-9. doi: 10.1053/j.jrn.2015.01.017. [Epub ahead of print]. PMID: 25812908

Palmer SC, Ruospo M, Campbell KL, Garcia Larsen V, Saglimbene V, Natale P, Gargano L, Craig JC, Johnson DW, Tonelli M, Knight J, Bednarek-Skublewska A, Celia E, Del Castillo D, Dulawa J, Ecder T, Fabricius E, Frazão JM, Gelfman R, Hoischen SH, Schön S, Stroumza P, Timofte D, Török M, Hegbrant J, Wollheim C, Frantzen L, Strippoli GF; DIET-HD Study investigators. Nutrition and dietary intake and their association with mortality and hospitalisation in adults with chronic kidney disease treated with haemodialysis: protocol for DIET-HD, a prospective multinational cohort study. BMJ Open. 2015 Mar 20;5(3):e006897. doi: 10.1136/bmjopen-2014-006897. PMID: 25795691

Li PK, Dorval M, Johnson DW, Rutherford P, Shutov E, Story K, Bargman JM. The Benefit of a Blucose-Sparing PD Therapy on Glycemic Control Measured by Serum Fructosamine in Diabetic Patients in a Randomised Controlled Trial (IMPENDIA). Nephron. 2015; 129(4):233-40. doi: 10.1159/000371554. Epub 2015 Mar 4. PMID: 25766261

Howard K, Hayes A, Cho Y, Cass A, Clarke M, Johnson DW. Economic Evaluation of Neutral-pH, Low-Glucose Degradation Product Peritoneal Dialysis Solutions Compared with Standard Solutions: A Secondary Analysis of the BalANZ Trial. Am J Kidney Dis. 2015 May; 65(5):773-9. doi: 10.1053/j.ajkd.2014.12.017. Epub 2015 Mar 4. PMID: 25746151

Fahim MA, Hayen A, Horvath AR, Dimeski G, Coburn A, Johnson DW, Hawley CM, Campbell SB, Craig JC. N-terminalpro-B-type natriuretic peptide variability in stable dialysis patients. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):620-9. doi: 10.2215/CJN.09060914. Epub 2015 Feb 24. PMID: 25714960

Nadeau-Fredette AC, Badve SV, Johnson DW. Daily home hemodialysis: balancing cardiovascular benefits with infectious harms. Am J Kidney Dis. 2015 Jan; 65(1):6-8. doi: 10.1053/j.ajkd.2014.08.012. No abstract available. PMID: 25523799

Palmer SC, Hanson CS, Craig JC, Strippoli GF, Ruospo M, Campbell K, Johnson DW, Tong A. Dietary and fluid restrictions in CKD: a thematic synthesis of patient views from qualitative studies. Am J Kidney Dis. 2015 Apr; 65(4):559-73. doi: 10.1053/j.ajkd.2014.09.012. Epub 2014 Nov 6. PMID: 25453993

Badve SV, Palmer SC, Johnson DW, Strippoli GF. A nephrology guide to reading and using systematic reviews of randomised trials. Nephrol Dial Transplant. 2015 Jun; 30(6):878-884. Epub 2014 Jun 23. Review. PMID: 24957810

Stevenson S, Tang W, Cho Y, Mudge DW, Hawley CM, Badve SV, Johnson DW. The Role of Monitoring Vancomycin Levels in Patients with Peritoneal Dialysis-Associated Peritonitis. Perit Dial Int. 2015 3-4;35(2):222-228. Epub 2014 Mar 1. PMID: 24584597

Publications - 2015

General


Trial Specific

Annie-Claire Nadeau-Fredette, Carmel Hawley, Elaine Pascoe, Christopher T. Chan, Martine Leblanc, Philip A. Clayton, Kevan R. Polkinghorne, Neil Boudville, and David W. Johnson. Predictors of Transfer to Home Hemodialysis after Peritoneal Dialysis Completion. Peritoneal Dialysis International, in press. DOE: 10.3747/pdi.2015.00121

HEROJohnson DW, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Scaria A, Walker R, Vergara LA, Hawley CM. A Randomized, Placebo-controlled Trial of Pentoxifylline on Erythropoiesis-Stimulating Agent Hyporesponsiveness in Anemic Patients in CKD: The Handling Erythropoietin Resistance with Oxpentifylline (HERO) Trial: American Journal of Kidney Disease, 2015. 65(1): 49-57, 2015. doi: 10.1053/j.ajkd.2014.06.020. Epub 2014 Aug 10 PMID: 25115616

Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogas E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis stimulating agent hyporesponsiveness: substudy of the HERO trial. Redox Report, IN PRESS.

Gummer J, Trengove R, Pascoe EM, Badve SV, Cass A, Clarke P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Carmel Hawley CM, Johnson DW, Olynk JK, Ferrari P on behalf of the HERO Study Collaborative Group. Association between Serum Hepcidin-25 and Primary Resistance to Erythropoiesis Stimulating Agents in Chronic Kidney Disease: A Secondary Analysis of the HERO Trial. Nephrology, IN PRESS

FAVOUREDViecelli AK, Pascoe E, Polkinghorne KR, Hawley C, Paul-Brent PA, Badve SV, Cass A, Heritier S, Kerr PG, Mori TA, Robertson A, Seong HL, Irish AB: FAVOURED Study Team. The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access Outcomes in Renal Disease (FAVOURED) study: Rationale of post-initiation trial modifications. BMC Nephrology, 2015. 16.89. DOI: 10.1186/s12882-015-0089-2 Accepted 17 June 2015

Viecelli AK, Pascoe E, Polkinghorne KR, Hawley CM, Paul-Brent P-A, Badve S, Cass A, Johnson DW, Kerr PG, Mori TA, Scaria A, Hooi LS, Ong LM, Irish AB, on behalf of the FAVOURED Study Team. Baseline characteristics of the omego-3 fatty acids (Fish Oils) and Aspirin in Vascular access Outcomes in Renal Disease (FAVOURED) Study. Nephrology, June 2015.

BLOCADERoberts MA, Pilmore HL, Ierino FL, Badve SV, Cass A, Garg AX, Hawley CM, Isbel NM, Krum H, Pascoe EM, Tonkin AM, Vergara LA, Perkovic V. BLOCADE Study Collaborative Group. The rationale and design of the beta-blocker to lower cardiovascular dialysis events (BLOCADE) Feasibility Study. Nephrology (Carlton), 2015. 20(3): 140-7. DOI: 10.1111/nep.12362.

Roberts MA, Pilmore HL, Ierino FL, Badve SV, Cass A, Garg AX, Hawley CM, Isbel NM, Krum H, Pascoe EM, Scaria A, Tonkin AM, Vergara LA, Perkovic V. BLOCADE Study Collaborative Group The Beta-blocker to Lower Cardiovascular Dialysis Events (BLOCADE) Feasibility Study. Am J Kidney Dis, Accepted October 2015 CKD-FIXBadve SV, Palmer SC, Hawley CM, Pascoe EM, Strippoli GFM, Johnson DW. Glomerular filtration rate decline as a surrogate endpoint in kidney disease progression trials. Nephrology Dialysis Transplantation, 2015. . DOI: 10.1093/ndt/gfv269

Conference AbstractsBadve SV. Mammalian Target of Rapamycin Inhibitors and Clinical Outcomes in Adult Kidney Transplant Recipients. In Abstracts of the Australian and New Zealand Society of Nephrology Annual Scientific Meeting, Canberra, 2015.

22 AKTN | Annual Report 2015 *Detailed financial statements available upon request. **Figures rounded to nearest whole value.

Assets/Income

Financial Overview - 2015

Total$3,882,049

Research Grants Received

$1,554,532

40%

Consulting Income Received

$3,833

Designated for Future Specific Research Project Expenditure

$2,323,684

<1%

60%


Total$1,742,857

Expenditure

Data Collection Costs Reimbursement to Study Sites

$552,195

32%

Investigational Product Control

$39,870

Research Project Management

$755,913

<2%

43%

Research Project Expenditure Research Support Infrastructure Expenditure

Equipment

$3,141

<1%

Staff Development

$10,793

1%

Equipment

$2,061

Management and General Operational Costs

$378,885

<1%

22%

24

AKTN - A Global Collaboration

The AKTN collaborates with sites all over the world. Currently, over 60 renal units in seven countries are engaged in AKTN trials including Australia, New Zealand, Malaysia, China, Mexico, the United States and the UK. As we grow, we expect to include even more countries in our list. If you are interested in collaborating with the AKTN and conducting one of our trials in your unit, please contact Donna Reidlinger at [email protected] or visit our website.

www.aktn.org.au


25

The University of Queensland, School of MedicineQueensland HealthThe George Institute for Global HealthThe Menzies School of Health ResearchThe University of AdelaideThe University of MelbourneThe University of Western AustraliaThe Centre for Kidney Disease ResearchCKD.QLDUK Kidney Research ConsortiumEuropean Vasculitis Clinical ConsortiumPA Research FoundationOttawa Hospital Research InstiutionThe National Health and Medical Research Council (NHMRC)NHMRC Clinical Trials Centre (Sydney)NZ Ministry of Health

The National Health ServiceThe Canadian Insititute of Health ResearchAustralian and New Zealand Society of NephrologyKidney Health AustraliaThe Royal Australasian College of PhysiciansAbbott LaboratoriesAmgen IncBaxterBayer AGComvita LtdFresenius SE & CoGamboJanssen-CilagPfizer IncRoche Product Pty LtdRoFar Foundation for Anemia ResearchShire PLC

Partners /Sponsors

The AKTN would like to thank all of its partners/sponsors for their help and support in making our clinical trials a reality. Together, we are improving the lives of those with Chronic Kidney Disease and with our organisation only growing, we look forward to what we can achieve together in the years to come.

Contact Us


Australasian Kidney Trials NetworkSchool of Medicine (SOM), The University of Queensland

Building 1, Level 4Princess Alexandra HospitalIpswich Road, WoolloongabbaQLD 4102, Australia

p +61 7 3176 5463e [email protected] www.aktn.org.au

If you are interested in joining the team, taking part in a trial or collaborating with the AKTN, please contact us for further information.

26

Australasian Kidney Trials Network

School of Medicine (SOM)The University of Queensland

Building 1, Level 4Princess Alexandra HospitalIpswich Road, WoolloongabbaQLD 4102, Australia

p +61 7 3176 5463e [email protected] www.aktn.org.au

© Australasian Kidney Trials Network

The mission of the Australasian Kidney Trials Network (AKTN) is to deliver high quality clinical trials to improve the health and wellbeing of people with Kidney Disease.

The AKTN operates within the UQ School of Medicine's Centre for Kidney Disease Research (CKDR).

annual report - kidney health australia · 2016-08-15 · annual report the australasian kidney...

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