PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease
NCT01581073 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 476
Last updated 2018-04-18
Summary
The purpose of this study is to ask whether treating non-diabetic chronic kidney disease (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and 13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to 11g/dL.
Conditions
Interventions
- DRUG
-
Darbepoetin alfa
Darbepoetin alfa is used for targeting Hb level of 11-13g/dL in high Hb group, and 9-11g/dL in low Hb group.
Sponsors & Collaborators
-
Showa University School of Medicine
collaborator UNKNOWN -
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-02-16
- Primary Completion
- 2017-12-07
- Completion
- 2017-12-07
Countries
- Japan
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