A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

• Registration Number: NCT00642304
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[SC\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-25
• Study Start: 2008-03-27
• Primary Completion: 2009-12-09
• Study Completion: 2009-12-09
• Results First Submitted: 2016-09-16
• Results First Submitted QC: 2016-09-16
• Results First Posted: 2016-11-06
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Chronic renal anemia
• Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks

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Exclusion Criteria

• Transfusion of red blood cells during previous 8 weeks
• Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
• Acute or chronic bleeding requiring therapy within previous 8 weeks

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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 [C.E.R.A.]	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)	EEP (Weeks 16 to 24)	The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Dose Adjustment	Baseline up to Week 20	A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.
Mean Change in Hb Concentration Between SVP and the EEP	SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)	The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP	EEP (Weeks 16 to 24)	The EEP was defined as Week 16 to Week 24.
Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP	EEP (Weeks 16 to 24)	The EEP was defined as Week 16 to Week 24.
Percentage of Participants With Blood Transfusion	Baseline up to Week 28

Trial Locations

Locations (23)

Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde; 🇳🇱 Dordrecht, Netherlands

Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde; 🇳🇱 Drachten, Netherlands

Oosterscheldeziekenhuis; 🇳🇱 Goes, Netherlands

Atrium Medisch Centrum; Nephrology; 🇳🇱 Heerlen, Netherlands

Bethesda Hospital; Internal Medicine; 🇳🇱 Hoogeveen, Netherlands

Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde; 🇳🇱 Leiderdorp, Netherlands

Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde; 🇳🇱 Maastricht, Netherlands

Leiden University Medical Center; Nierziekten; 🇳🇱 Leiden, Netherlands

Academisch Ziekenhuis St. Radboud; Nierziekten Afd.; 🇳🇱 Nijmegen, Netherlands

Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde; 🇳🇱 Rotterdam, Netherlands

Mc Rijnmond Zuid - Locatie Clara; Infectieziekten; 🇳🇱 Rotterdam, Netherlands

Ikazia Ziekenhuis; Interne Oncologie; 🇳🇱 Rotterdam, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

Bovenij Zkhs; Cardiologie Afd.; 🇳🇱 Amsterdam, Netherlands

Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases; 🇳🇱 Amersfoort, Netherlands

Wilhelmina Ziekenhuis; Inwendige Geneeskunde; 🇳🇱 Assen, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

Zorgsaam Ziekenhuis; 🇳🇱 Terneuzen, Netherlands

Twenteborg Ziekenhuis; 🇳🇱 Almelo, Netherlands

Rode Kruis Ziekenhuis; Inwendige Geneeskunde; 🇳🇱 Beverwijk, Netherlands

Slingeland Ziekenhuis; Inwendige Geneeskunde; 🇳🇱 Doetinchem, Netherlands

Reinier De Graaf Groep; 🇳🇱 Delft, Netherlands

Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde; 🇳🇱 Gouda, Netherlands