A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia

Phase 3

Completed

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

• Registration Number: NCT00605293
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-01-18
• Study First Posted: 2008-01-31
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-10
• Results First Submitted: 2016-04-08
• Results First Submitted QC: 2016-04-08
• Last Update Submitted: 2016-04-08
• Results First Posted: 2016-05-13
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• chronic renal anemia;
• continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
• regular hemodialysis for greater than or equal to (>=) 3 months

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Exclusion Criteria

• transfusion of red blood cells during previous 2 months
• poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epoetin Alfa	Epoetin alfa	Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), and 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
C.E.R.A	methoxy polyethylene glycol-epoetin beta	Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP	EEP (Week 16 to 23)	Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP	EEP (Week 16 to 23)	Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.
Percentage of Participants Who Required Dose Adjustments During the DTP and EEP	DTP (Week 0 to 15) and EEP (Week 16 to 23)
Change in Hb Concentrations Between Baseline SVP and the EEP	SVP (Week -4 to -1), EEP (Week 16 to 23)	Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).
Mean Time Spent in Hb Range 10-12 g/dL	SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)
Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP	DTP (Week 0 to 15) up to EEP (Week 16 to 23)	RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).