Trial intelligence / Profile preview

Mircera vs Darbepoetin Alfa for Anemia in Renal Transplant Recipients

NCT00605345Phase 3

Key facts

Status
Completed
Start
Dec 2007
Primary completion
Jul 2009
Countries
1
Sponsor
Roche
Modality
rProtein (Recombinant Protein), Biologic
Conditions
anemia of chronic kidney disease
01

Overview

Phase 3, randomised, open-label trial of methoxy polyethylene glycol-epoetin beta in anemia of chronic kidney disease, sponsored by Roche. Primary endpoint: Percentage of Participants Maintaining Average Haemoglobin Concentration Within Target Range at 28 weeks. Started Dec 2007; status: completed.

02

Design

Study design
RandomizedOpen-label
03

Who it enrols

Adult kidney transplant recipients with stage 3 or 4 chronic kidney disease and a functioning graft (6 months to 10 years post-transplant) who are on stable maintenance subcutaneous darbepoetin alfa therapy.

04

Endpoints

Primary

  • Percentage of Participants Maintaining Average Haemoglobin Concentration Within Target Range

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