A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; Drug: darbepoetin alfa

• Registration Number: NCT00081471
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-04-13
• Study First Submitted QC: 2004-04-15
• Study First Posted: 2004-04-16
• Study Start: 2004-06
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• adult patients >=18 years of age;
• chronic kidney disease;
• anemia;
• not on dialysis therapy;
• not receiving epoetin.

Exclusion Criteria

• women who are pregnant, breastfeeding or using unreliable birth control methods;
• administration of another investigational drug within 4 weeks before screening, or during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	methoxy polyethylene glycol-epoetin beta [Mircera]	-
2	darbepoetin alfa	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin response rate	Weeks 1-28

Secondary Outcome Measures

Name	Time	Method
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n	Throughout study