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Improving outcomes in advanced
CKD and the transition to dialysis
Elodie Speyer, PhD
on behalf of CKDopps and CKD-REIN Investigators
EDTNA 2017 Congress, DOPPS Clinical Symposium
Krakow, Poland
Sept, 10th 2017
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CKDopps: Outline
1. Study overview
2. Practice patterns
3. What patients tell us
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CKDopps – Overall goal and design
• The CKD Outcomes and Practices Patterns Study (CKDopps)
• International, prospective cohort study of CKD patients receiving
nephrologist care (based on national samples of nephrology
clinics)
• Identify nephrologist practices associated with better outcomes in
advanced CKD patients and during kidney failure transition
• CKDopps initiative may have a lasting influence on CKD care, as
DOPPS has had on HD care since its launch in 1996.
• Public and industry funding
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Design Target ≈ 12,000 CKD patients
Inclusion
criteria
• Adult patients ( ≥18 years)
• All causes of CKD stage 3b to 5 (non dialysis,
non-renal transplant)
- Stage 3-4 in France
• 60-80 per clinic
Follow-up • 3 years (up to 5 years in France)
• Before and after starting RRT
Extensive data
collection
(longitudinal)
• Patient-level data (medical records & PRO) - Routine lab data (vs requested in France)
- No patient-questionnaire in Germany
• Physician-, and clinic-level data
Outcomes • Mortality and morbidity
• Progression and transition to kidney failure
• Patient-reported outcomes and experience
Patients and information
More details in Mariani et al. Am J Kidney Dis. 2016 Sep;68(3):402-13
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Brazil
France
Germany
United States
CKDopps participating countries Current as of August 24, 2017
32 clinics
(target=30)
1,810 patients
(target = 1,800)
40 clinics
(target=40)
3,033 patients
(target=3,200)
32 clinics
(target=40)
1,425 patients
(target=3,200)
18 clinics
(target=20)
995 patients
(target=1,600)
Japan
31 clinics
(target=30)
2,201 patients
(target=2,400)
Currently enrolled ~ 9,465 of targeted 12,000 patients
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Baseline patient characteristics
Brazil France Germany US
Patients, N 909 3,033 1,829 1,251
Median age (years) 67 69 75 71
Women 47% 35% 42% 47%
Diabetesa 48% 41% 43% 59%
Mean eGFR, mL/min/1.73 m2
25.8 32.9 27.7 26.4
CKD Cause
Diabetes 32% 20% 27% 35%
Glomerular Disease 8% 17% 10% 6%
Hypertension 30% 21% 33% 33%
Other/Unknown 30% 42% 30% 26%
a. 5, 2, 2, 4 % of all patients in Brazil, France, Germany, US were type 1 diabetics
b. ** Japanese data not available yet (enrollment started in 2016)
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Country N Pts Follow-up Time,
Median years
Dialysis
Starts,
% (n)
Deaths**,
% (n)
Hospitalizations†,
% (n)
Brazil 909 1.20 9% (78) 6% (51) 17% (155)
France 3,012 1.99 8% (258) 8% (237) 58% (1774)
Germany 1,829 3.10 22% (396) 13% (234) -
United States 1,251 1.21 13% (168) 12% (156) 28% (345)
CKDopps Total 6,894 13% (900) 10% (678) 32% (2274)
CKDopps Outcomes*
* Japanese data not available yet (enrollment started in 2016)
** Deaths captured during study follow-up (including up to 12 months after start of dialysis) † Inpatient hospitalization
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CKDopps: Outline
1. Study overview
2. Practice patterns
3. What patients tell us
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49
34 27 24 29 26
42 36
21
21 21
19 22 27
22 20
18
31 33
36
41 33
25 31
14 14 19 21 8
14 11 13
0
25
50
75
100
3 4/5 3 4/5 3 4/5 3 4/5
160+
140-159
130-139
< 130
SBP, mmHg
Stage
Systolic blood pressure, by CKD stage
KDIGO 2012: Individualize BP targets; avoid postural hypotension
% of patients
Brazil
N=714
France
N=2898
Germany
N=1230
US
N=1160
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Timing of first nephrology visit before starting
dialysis
KDIGO 2012
Timely referral for RRT planning if
progressive CKD with 1-year ESKD
risk at least 10-20% (using validated
risk prediction tool)
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19
1 13
28
12
25
23
28
31
19
28
15
11
31
17
0
20
40
60
80
100
Brazil 74
France 251
US 159
>10 years
6-10 years
3-6 year
1-3 years
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eGFR at dialysis initiation (DOPPS)*
7 4 10 10
17 10 13 9
17 18 22
28 31 34
13 17
19 19
29
29 31
33
35 39
39
37 30
43
22 25
21 26
22 33 31 33
27 21
20 14 24
18
23 21 18
24
12
14 13
18 10 12 9 11
6
3
35 33 33
22 20 14 13
8 12 11 10 10 9
2
0
20
40
60
80
100
Bel
227 …
Ger
346 …
US
526 …
Can
218 …
ANZ
90 …
Spa
319 …
UK
197 …
Fra
89 …
Ita
202 …
Swe
286 …
Jpn
446 …
Chi
120 …
Rus
70 …
GCC
145 …
12.5+
10-12.4
7.5-9.9
5.0-7.4
< 5.0
N Pts: Mean:
Adapted from Bieber et al. ASN abstract (2013) * 2009-2014
% of patients 20% 60%
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CKDopps: Outline
1. Study overview
2. Practice patterns
3. What patients tell us
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Patient’s general health
1 2 0 1 1 2 10 5 4 3
15 12
47
39
63 53
45 38
32
34
28
36 32
39
10 20
5 8 7 9
0
20
40
60
80
100
3 183
4/5 370
3 1 328
4/5 1 098
3 244
4/5 445
Poor
Fair
Good
Very good
Excellent
N Pts =
Enrollment Patient Questionnaire data
Stage
Brazil US
% of patients
France
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23 21 22
39
25 21
36
26 30
47
34 36
0
20
40
60
80
100
Brazil France** US
3a 3b 4 5 CKD stage
Enrollment Patient Questionnaire data
Patients reporting to have
seen a dietician at least once during past year
% of patients
KDIGO 2012
Provide expert dietary advice and
information in the context of an education
program, … on salt, phosphate,
potassium, and protein intake (1B)
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5 5 10
23
10 15
22 19
31
21
40
53
0
20
40
60
80
100
Brazil France** US
3a 3b 4 5 CKD stage
Percentage of patients who reported
receiving education sessions* about treatment
options for kidney failure
* Either one-on-one or a classroom education sessions
% of patients
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“Which of treatment options for kidney failure has
your doctor discussed with you?” Among patients with eGFR
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“Which of treatment options for kidney failure has
your doctor discussed with you?” Among patients with eGFR
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CKDopps: Take-Home Messages
Early data show:
• Important variations already identified across countries
About practice patterns:
• Study is ongoing, but a high number of outcomes have already been recorded
• Uncontrolled SBP > 140 mm Hg remains high
• Late nephrologist referral is most common in Brazil
What patients tell us:
• A certain burden of kidney disease for patients
• Many don’t regurlarly see a dietician or receive advice regarding treatment options for kidney failure (recall bias?)
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CKDopps: Special Thanks
• CKDopps Investigators
– Arbor Research: B. Robinson, R. Perlman, RL. Pisoni, F. Port
– Brazil: R. Bueno de Oliveira, AA. Lopes, J. Lugon, R. Pecoits-Filho, R. Sesso,
D. Rinaldo dos Santos
– France: B. Stengel, ZA. Massy, C. Combe, C. Jacquelinet, M. Laville, D.
Fouque, L. Frimat, S. Briançon, C. Pascal, YE Herpe, JF. Deleuze, J. Schanstra,
P. Morel
– Germany: H. Reichel, D. Fliser, J. Duttlinger, G. Lonnemann
– Japan: K. Yamagata, T. Wada
• All clinical investigators and CRAs for invaluable contributions.
• All patients for their participation.
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CKDopps: Special Thanks
• Sponsorship – Brazil – Support provided in part by Keryx
– France – Affiliated with CKD-REIN which is funded by a public-private partnership including grants from Agence Nationale de la Recherche Programme "Investissements Avenir",
Programme Hospitalier de Recherche Clinique PHRC 2010 and 6 industrial partners : Amgen,
Baxter, Fresenius, Lilly, MSD, Otsuka
– Germany – Affiliated with the Scientific Institute for Nephrology (WiNe Institute)
– Japan – Affiliated with Reach-J supported in part by a Grant-in-Aid for Research
on Advanced CKD, Practical Research Project for Renal Diseases from Japan
Agency for Medical Research and Development (AMED)
– U.S. – Support provided in part by Keryx