A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia

Hoffmann-La Roche351 enrolled

Overview

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent \[ESA\] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

351

Conditions

Anemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic renal anemia; * Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month; * Regular long term hemodialysis therapy with the same mode of dialysis for \>=3 months. Exclusion Criteria: * Transfusion of red blood cells during previous 2 months; * Significant acute or chronic bleeding, such as overt gastrointestinal bleeding; * Active malignant disease (except non-melanoma skin cancer).

Locations (60)

Unnamed facility

Acireale, Italy

Unnamed facility

Ancona, Italy

Unnamed facility

Anzio, Italy

Unnamed facility

Arenzano, Italy

Unnamed facility

Ascoli Piceno, Italy

Unnamed facility

Avellino, Italy

Outcomes

Primary Outcomes

Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference 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 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis 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 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 -4 up to Week 0 and Week 17 up to Week 24

Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range

Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.

Time frame: Week 17 up to Week 24

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

Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.

Time frame: Week 17 up to Week 24

Percentage of Participants Requiring Any Dose Adjustment

Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.

Time frame: Week 1 up to Week 16 and Week 17 up to Week 24

Number of Participants With Red Blood Cell Transfusion During the Study

Number of participant who underwent red blood cell transfusion during the study was reported.

Time frame: Week -4 up to Week 52