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

Anemia Clinical Trial

Official title:

A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642304
• Other study ID #: ML20937
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2008
• Est. completion date: December 9, 2009

Study information

• Verified date: March 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 9, 2009
• Est. primary completion date: December 9, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic renal anemia

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

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.

Locations

Country	Name	City	State
Netherlands	Twenteborg Ziekenhuis	Almelo
Netherlands	Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases	Amersfoort
Netherlands	Bovenij Zkhs; Cardiologie Afd.	Amsterdam
Netherlands	Wilhelmina Ziekenhuis; Inwendige Geneeskunde	Assen
Netherlands	Rode Kruis Ziekenhuis; Inwendige Geneeskunde	Beverwijk
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Reinier De Graaf Groep	Delft
Netherlands	Slingeland Ziekenhuis; Inwendige Geneeskunde	Doetinchem
Netherlands	Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde	Dordrecht
Netherlands	Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde	Drachten
Netherlands	Oosterscheldeziekenhuis	Goes
Netherlands	Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde	Gouda
Netherlands	Atrium Medisch Centrum; Nephrology	Heerlen
Netherlands	Bethesda Hospital; Internal Medicine	Hoogeveen
Netherlands	Leiden University Medical Center; Nierziekten	Leiden
Netherlands	Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde	Leiderdorp
Netherlands	Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde	Maastricht
Netherlands	Academisch Ziekenhuis St. Radboud; Nierziekten Afd.	Nijmegen
Netherlands	Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde	Rotterdam
Netherlands	Ikazia Ziekenhuis; Interne Oncologie	Rotterdam
Netherlands	Mc Rijnmond Zuid - Locatie Clara; Infectieziekten	Rotterdam
Netherlands	Zorgsaam Ziekenhuis	Terneuzen
Netherlands	Diakonessenhuis	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	EEP (Weeks 16 to 24)
Secondary	Mean Change in Hb Concentration Between SVP and the EEP	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.	SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
Secondary	Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP	The EEP was defined as Week 16 to Week 24.	EEP (Weeks 16 to 24)
Secondary	Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP	The EEP was defined as Week 16 to Week 24.	EEP (Weeks 16 to 24)
Secondary	Percentage of Participants With Blood Transfusion		Baseline up to Week 28
Secondary	Percentage of Participants With Dose Adjustment	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.	Baseline up to Week 20