Japan Erythropoietin Treatment-Strvey for starting hemoglobin level in renal anemia management
- Conditions
- Renalanemic CKD patients in non-dialysis
- Registration Number
- JPRN-UMIN000003116
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO.,LTD.
- Brief Summary
In this prospective, multi-center, observational study, non-dialysis CKD patients with anemia who were naive to erythropoiesis-stimulating agents (ESAs) were divided into 3 groups based on their Hb levels at initiation of epoetin beta therapy (Group I: 10 <= Hb < 11 g/dL, Group II: 9 <= Hb < 10 g/dL, and Group III: Hb < 9 g/dL). The primary endpoint was time to first occurrence of any renal event. For the primary analysis, an inverse probability weighted Cox regression model was used to adjust time-dependent selection bias in the artificially censored data. A total of 1113 patients were eligible for primary endpoint analysis. Risk of renal events was significantly higher in Group III compared with Group I (HR, 2.52; 95% CI, 1.98 to 3.21; P < 0.0001); although not significant, the risk was also higher in Group II compared with Group I (HR, 1.48; 95% CI, 0.91 to 2.40; P = 0.11). Initiation of ESA therapy when Hb levels decreased below 11 g/dL but not below 10 g/dL could be more effective at reducing the risk of renal events in non-dialysis CKD patients with anemia compared with initiation of ESA therapy at below 9 g/dL or even 10 g/dL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 2000
Not provided
The following patients will be excluded: 1)Patients with anemia caused by a condition other than renal anemia 2)Patients whose eGFR is less than 6 mL/min/1.73m2
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method