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

Hoffmann-La Roche20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

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

...and 13 more locations

Outcomes

Primary Outcomes

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.

Time frame: EEP (Weeks 16 to 24)

Secondary Outcomes

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.

Time frame: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)

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.

Time frame: EEP (Weeks 16 to 24)

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.

Time frame: EEP (Weeks 16 to 24)

Percentage of Participants With Blood Transfusion

Time frame: Baseline up to Week 28

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.

Time frame: Baseline up to Week 20

Data from ClinicalTrials.gov

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