A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

Hoffmann-La Roche35 enrolled

Overview

This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult participants, \>=18 years of age; * Chronic renal anemia; * No ESA therapy during previous 3 months. Exclusion Criteria: * Transfusion of red blood cells during previous 2 months; * Poorly controlled hypertension requiring hospitalization in previous 6 months; * Significant acute or chronic bleeding.

Locations (32)

ASZ Aalst

Aalst, Belgium

ZNA Middelheim

Antwerp, Belgium

ZNA Stuivenberg

Antwerp, Belgium

AZ Sint Lucas Brugge

Assebroek, Belgium

CH EpiCURA Site Ath

Ath, Belgium

CH EpiCURA Site Louis Caty

Baudour, Belgium

Imeldaziekenhuis

Bonheiden, Belgium

Clinique Saint-Jean- Botanique

Brussels, Belgium

CHU Brugmann (Victor Horta)

Brussels, Belgium

Clin Univ de Bxl Hôpital Erasme

Brussels, Belgium

...and 22 more locations

Outcomes

Primary Outcomes

Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range

The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.

Time frame: Weeks 29-36

Secondary Outcomes

Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)

The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.

Time frame: Weeks 0-36

Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)

Time frame: Weeks 29-36

Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)

Time frame: Weeks 29-36

Percentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Time frame: Weeks 1-40