A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Phase 3TerminatedNCT00422513

Hoffmann-La Roche260 enrolled

Overview

This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

260

Conditions

Anemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, \>=18 years of age; * CKD (stage V) on outpatient hemodialysis therapy for \>= 3 months; * CKD-related anemia treated with epoetin alfa iv 3x/week for \>= 3 months; * average hemoglobin (Hb) 10-12 g/dL over last 3 months. Exclusion Criteria: * failed renal transplant within 12 months prior to screening; * poorly controlled hypertension; * previous treatment with Mircera.

Locations (44)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Rainbow City, Alabama, United States

Unnamed facility

Hot Springs, Arizona, United States

Unnamed facility

Fairfield, California, United States

Unnamed facility

Los Alamitos, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Time Spent on Anemia Treatment Over Evaluation Period

Efficacy and pharmacoeconomics analyses were not performed.

Time frame: Months 5-7

Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period

Efficacy and pharmacoeconomics analyses were not performed.

Time frame: Baseline, Months 5-7

Secondary Outcomes

Number of Participants Assessed for AEs

The adverse events are captured in the adverse event and serious adverse event section of this database.

Time frame: Month 1 to 15 day follow up post month 7

The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants

A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.

Time frame: Baseline, Month 1 to Month 7