A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)

• Registration Number: NCT00699348
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent \[ESA\] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Study Start: 2008-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2016-03
• Results First Submitted: 2016-03-08
• Results First Submitted QC: 2016-03-08
• Last Update Submitted: 2016-03-08
• Results First Posted: 2016-04-06
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

• Chronic renal anemia;
• Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month;
• Regular long term hemodialysis therapy with the same mode of dialysis for >=3 months.

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Exclusion Criteria

• Transfusion of red blood cells during previous 2 months;
• Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
• Active malignant disease (except non-melanoma skin cancer).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C.E.R.A.	Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range	Week 17 up to Week 24	Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range	Week 17 up to Week 24	Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP	Week 17 up to Week 24	Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
Number of Participants With Red Blood Cell Transfusion During the Study	Week -4 up to Week 52	Number of participant who underwent red blood cell transfusion during the study was reported.
Change in Hemoglobin Concentration Between Reference SVP and EEP	Week -4 up to Week 0 and Week 17 up to Week 24	The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.
Percentage of Participants Requiring Any Dose Adjustment	Week 1 up to Week 16 and Week 17 up to Week 24	Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.