Trial information
A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
Status: Completed
Protocol number: M67005
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study comparing the effects of low-dose cyclosporine vs cyclosporine withdrawal on renal function in kidney transplant patients treated with CellCept and daclizumab
Brief summary: This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.
Target sample size is 525.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil [CellCept]
Primary outcome: 1. Renal function (as measured by GFR) Time frame: 12 months post-transplant
Key secondary outcomes: 1. Patient and graft survival
Time frame: 12 months post-transplant
2. Proportion of patients with biopsy-proven rejection; treatment failure. Time frame: 6 and 12 months post-transplant
3. AEs, OIs, malignancies, deaths Time frame: Throughout study
Inclusion criteria:
- adult patients greater than 18 years of age
- recipients of primary kidney transplant
- single-organ recipients (kidney only)
Exclusion criteria:
- previous treatment with Zenapax
- history of malignancy (except localized skin cancer)
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Belgium
Canada
- Calgary, AB
- Edmonton, AB
- Vancouver, BC
- Saskatoon, SK
France
Germany
Mexico
Norway
Poland
Spain
- Barcelona
- Córdoba
- Malaga
- Santander
- Valencia
Sweden
United Kingdom
- Birmingham
- Glasgow
- Leicester
United States
- Birmingham, AL
- San Francisco, CA
- Livingston, NJ
- Philadelphia, PA
- Charleston, SC
- Falls Church, VA
