A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

Hoffmann-La Roche127 enrolled

Overview

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Anemia

Interventions

Methoxy Polyethylene Glycol-epoetin Beta

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis; * continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month. Exclusion Criteria: * transfusion of red blood cells during previous 2 months; * significant acute or chronic bleeding; * poorly controlled hypertension.

Locations (69)

Unnamed facility

Aix-en-Provence, France

Unnamed facility

Angers, France

Unnamed facility

Angers, France

Unnamed facility

Annonay, France

Unnamed facility

Avignon, France

Unnamed facility

Bastia, France

Outcomes

Primary Outcomes

Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period

Time frame: Weeks 16-24

Secondary Outcomes

Mean change in Hb concentration

Time frame: Between reference and Efficacy Evaluation Period

Mean time spent in Hb range

Time frame: Weeks 16-24

% patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions

Time frame: Weeks 16-48

AEs, lab parameters

Time frame: Throughout study