A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Methoxy polyethylene glycol-epoetin beta

• Registration Number: NCT00660023
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Study Start: 2008-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2016-02
• Results First Submitted: 2016-02-16
• Results First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Results First Posted: 2016-03-15
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Adults greater than or equal to (≥) 18 years of age
• Chronic renal anemia
• Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
• Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months

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Exclusion Criteria

• Transfusion of red blood cells during previous 2 months
• Poorly controlled hypertension
• Significant acute or chronic bleeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mircera in Renal Anemia	Methoxy polyethylene glycol-epoetin beta	Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)	Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24	Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Time-Adjusted Hb From Baseline to EEP	At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24	Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.
Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP	Pre-dose (0 hours) during Weeks 18, 20, 22, and 24	During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.
Mean Time Spent in the Target Range for Hb During the EEP	Pre-dose (0 hours) during Weeks 18, 20, 22, and 24	During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.
Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP	Weeks 0, 4, 8, 12, 16, 20, and 24	Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP	Weeks 0, 4, 8, 12, 16, 20, and 24	Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.
Number of Participants Receiving Blood Transfusion During the DTP and EEP	Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24	The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.
Number of Blood Transfusions During the DTP and EEP	Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24	The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.