Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia

Phase 3TerminatedNCT00517881

Hoffmann-La Roche29 enrolled

Overview

This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa 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.)DRUG

Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic renal anemia * Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL * Adequate iron status (serum ferritin greater than \[\>\] 100 nanogram per milliliter and Transferrin Saturation \>20 percent \[%\] or hypochromic red cells less than \[\<\] 10%) * Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months Exclusion Criteria: * Transfusion of red blood cells during previous 2 months * Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months * Acute or chronic bleeding * Active malignant disease (except non-melanoma skin cancer)

Locations (14)

Unnamed facility

Danderyd, Sweden

Unnamed facility

Eksjö, Sweden

Unnamed facility

Eskilstuna, Sweden

Unnamed facility

Gävle, Sweden

Outcomes

Primary Outcomes

Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range

Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.

Time frame: Week 17 up to Week 24

Secondary Outcomes

Change in Hemoglobin Concentration Between Reference (SVP) and EEP

The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.

Time frame: Week 17 up to Week 24

Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP

Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.

Time frame: Week 17 up to Week 24

Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.

Time frame: Week 17 up to Week 24

Percentage of Participants Requiring Any Dose Adjustment

Data from ClinicalTrials.gov

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