A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia

Hoffmann-La Roche101 enrolled

Overview

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Anemia

Interventions

methoxy polyethylene glycol-epoetin beta

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * chronic renal anemia; * continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP; * regular hemodialysis for greater than or equal to (\>=) 3 months Exclusion Criteria: * transfusion of red blood cells during previous 2 months * poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;

Locations (19)

Unnamed facility

Badajoz, Badajoz, Spain

Unnamed facility

Barcelona, Barcelona, Spain

Unnamed facility

Cáceres, Caceres, Spain

Unnamed facility

Cádizv, Cadiz, Spain

Unnamed facility

Castellon, Castellon, Spain

Unnamed facility

Ciudad Real, Ciudad Real, Spain

Unnamed facility

Huelva, Huelva, Spain

Unnamed facility

Madrid, Madrid, Spain

Unnamed facility

Madrid, Madrid, Spain

Unnamed facility

Madrid, Madrid, Spain

...and 9 more locations

Outcomes

Primary Outcomes

Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP

Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.

Time frame: EEP (Week 16 to 23)

Secondary Outcomes

Change in Hb Concentrations Between Baseline SVP and the EEP

Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).

Time frame: SVP (Week -4 to -1), EEP (Week 16 to 23)

Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP

Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.

Time frame: EEP (Week 16 to 23)

Mean Time Spent in Hb Range 10-12 g/dL

Time frame: SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)

Percentage of Participants Who Required Dose Adjustments During the DTP and EEP

Time frame: DTP (Week 0 to 15) and EEP (Week 16 to 23)

Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP

RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).

Time frame: DTP (Week 0 to 15) up to EEP (Week 16 to 23)