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MISTRAL Study: A Study of Monthly Subcutaneous Mircera for Maintenance Treatment of Patients With Chronic Kidney Disease on Peritoneal Dialysis.

Anemia Clinical Trial

Official title:
A Single Arm, Open-label, Multi-center Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Mircera in Patients With Chronic Kidney Disease on Peritoneal Dialysis

Clinical Trial Summary

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic kidney disease on peritoneal dialysis. Patients currently receiving maintenance treatment with subcutaneous ESA will receive monthly subcutaneous injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00737477
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date December 2011
View Details
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