A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Phase 3

Terminated

• Conditions: Anemia
• Interventions: Drug: Epoetin alfa; Drug: methoxy polyethylene glycol-epoetin beta

• Registration Number: NCT00422513
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. 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: 2007-01-15
• Study First Submitted QC: 2007-01-15
• Study First Posted: 2007-01-17
• Study Start: 2007-03
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2011-03-29
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-09
• Last Update Submitted: 2011-11-09
• Results First Posted: 2011-12-14
• Last Update Posted: 2011-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• adult patients, >=18 years of age;
• CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;
• CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;
• average hemoglobin (Hb) 10-12 g/dL over last 3 months.

Exclusion Criteria

• failed renal transplant within 12 months prior to screening;
• poorly controlled hypertension;
• previous treatment with Mircera.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epoetin Alfa	Epoetin alfa	As prescribed, (iv), 3 times weekly
methoxy polyethylene glycol-epoetin beta	methoxy polyethylene glycol-epoetin beta	120-360 micrograms (iv) monthly, starting dose

Primary Outcome Measures

Name	Time	Method
Time Spent on Anemia Treatment Over Evaluation Period	Months 5-7	Efficacy and pharmacoeconomics analyses were not performed.
Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period	Baseline, Months 5-7	Efficacy and pharmacoeconomics analyses were not performed.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Assessed for AEs	Month 1 to 15 day follow up post month 7	The adverse events are captured in the adverse event and serious adverse event section of this database.
The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants	Baseline, Month 1 to Month 7	A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.