A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa; Hematinics

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• kidney transplant >=6 months and <5 years prior to randomization;

• anemia;

• no ESA therapy during 3 months prior to randomization.

Exclusion Criteria:

• requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization;

• change in Hb concentration >=1.5g/dL during screening period;

• transfusion of red blood cells during 3 months prior to randomization;

• poorly controlled hypertension;

• significant acute or chronic bleeding within 3 months prior to randomization.