Clinical Trial Details
| Trial ID: | L0367 |
| Source ID: | NCT01581073 |
| Associated Drug: | Darbepoetin Alfa |
| Title: | PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease |
| Acronym: | PREDICT |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Diabetes |
| Interventions: | DRUG: Darbepoetin alfa |
| Outcome Measures: | Primary: Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value., 96 weeks | Secondary: Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, leg amputation, admission by heart failure or angina., 96 weeks|Time from enrollment to initiation of dialysis, 96 weeks|Time from enrollment to 50% reduction of eGFR from initial value, 96 weeks|Time from enrollment to death by any cause, 96 weeks|Change of eGFR from enrollment, 96 weeks|Change of proteinuria/Cr ratio, 96 weeks|Renal protection in patients who maintained the target Hb more than half the time, 96 weeks|50% renal survival, 96 weeks|Stroke, 96 weeks|Myocardial infarction, 96 weeks|Development of malignancy, 96 weeks|Number of Participants with Adverse Events baseline, 96 weeks |
| Sponsor/Collaborators: | Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Collaborators: Showa University School of Medicine |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 476 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-02-16 |
| Completion Date: | 2017-12-07 |
| Results First Posted: | |
| Last Update Posted: | 2018-04-18 |
| Locations: | Showa University School of Medicine, Shinagawa, Tokyo, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01581073 |
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