A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

• Registration Number: NCT00773968
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2016-03
• Results First Submitted: 2016-03-04
• Results First Submitted QC: 2016-03-04
• Last Update Submitted: 2016-03-04
• Results First Posted: 2016-04-04
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Chronic renal anemia;
• Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
• Hb concentration between 10 and 12 g/dL;
• Adequate iron status.

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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;
• Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
• Active malignant disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methoxy Polyethylene Glycol-Epoetin Beta	Methoxy Polyethylene Glycol-Epoetin Beta	Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)	EEP: Weeks 17 to 28	The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).

Secondary Outcome Measures

Name	Time	Method
Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)	SVP: Week -4 to Week 0; EEP: Weeks 17 to 28	Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.
Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP	EEP: Weeks 17 to 28
Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP	EEP: Weeks 17 to 28
Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP	DTP: Weeks 1 to 16; EEP: Weeks 17 to 28	The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was \>1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.
Percentage of Participants Who Required Red Blood Cell Transfusions	Weeks 1 to 28