A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients

Phase 3

Completed

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

• Registration Number: NCT00081484
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months 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: 2006-03
• Study Completion: 2006-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

• adult patients >=18 years of age;
• chronic renal anemia;
• on dialysis therapy for at least 12 weeks before screening;
• receiving iv or sc epoetin for at least 8 weeks before screening.

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	epoetin alfa or beta	-

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin concentration	Weeks 1-36

Secondary Outcome Measures

Name	Time	Method
AEs, laboratory parameters, vital signs	Throughout study
Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration	Weeks 29-36
RBC transfusions	Weeks 1-36