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Erschienen in:
01.02.2016 | Original Article
Rationale and study design of a randomized controlled trial to assess the effects of maintaining hemoglobin levels using darbepoetin alfa on prevention of development of end-stage kidney disease in non-diabetic CKD patients (PREDICT Trial)
Erschienen in: Clinical and Experimental Nephrology | Ausgabe 1/2016
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Background
Anemia associated with high mortality is a common complication of chronic kidney disease (CKD). Target hemoglobin (Hb) levels for CKD treatment remain controversial: Recent guidelines recommend a maximum of 13 g/dL to avoid increased risk of CVD. However, some smaller studies show slower progression of renal function loss with high Hb targets. Recently, darbepoetin alfa targeting Hb 11–13 g/dL was reported to improve renal composite outcome of Japanese patients compared with a low Hb group maintained at 9.0–11.0 g/dL using epoetin alfa (HR 0.66; 95 % CI 0.47–0.93). The high Hb group showed significant reduction of left ventricular mass index and improved quality of life. Sub-analysis revealed greater beneficial effects in non-diabetic stage 5 CKD patients. This randomized controlled trial, PREDICT, aims to confirm the impact of targeting Hb levels of 11–13 g/dL using darbepoetin alfa with reference to a low Hb target of 9–11 g/dL.
Methods
We calculated the number of subjects (N = 440) necessary to detect a statistically significant level of α = 0.05 (two-sided) and statistical power of 80 % for a minimum follow-up period of 2 years on the basis of a previous study.
Results
The study enrolled 498 non-diabetic Japanese patients with eGFR 8–20 mL/min/1.73 m2. The primary outcome is a composite renal endpoint (starting chronic dialysis, transplantation, eGFR 6 mL/min/1.73 m2 or less, 50 % decrease in eGFR). Average follow-up period is 2 years and the study ends in 2016.
Conclusion
PREDICT will determine the optimum target Hb for Japanese patients with non-diabetic CKD.
(ClinicalTrials.gov No. NCT01581073).