A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation
Intervention: Corticosteroids (Drug); Neoral (Drug); Neoral (Drug); Zenapax (Drug); mycophenolate mofetil [CellCept] (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Renal function (as measured by GFR)
Secondary outcome: Patient and graft survival \nProportion of patients with biopsy-proven rejection; treatment failure. AEs, OIs, malignancies, deaths
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Adelaide 5011, Australia
Sydney 2050, Australia
Bruxelles 1070, Belgium
Leuven 3000, Belgium
Vandoeuvre-les-nancy 54511, France
Berlin 13353, Germany
Hannover 30625, Germany
Muenster 48149, Germany
Mexico City 06720, Mexico
Monterrey 06720, Mexico
Oslo 0027, Norway
Warszawa 02-006, Poland
Wroclaw 50-417, Poland
Barcelona 08036, Spain
Barcelona 08907, Spain
Córdoba 14004, Spain
Malaga 29010, Spain
Santander 39008, Spain
Valencia 46009, Spain
Goeteborg 41345, Sweden
Malmoe 20502, Sweden
Birmingham B15 2TH, United Kingdom
Glasgow G11 6NT, United Kingdom
Leicester LE5 4PW, United Kingdom
Birmingham, Alabama 35294, United States
Calgary, Alberta T2N 2T9, Canada
Edmonton, Alberta T6G 2R8, Canada
Vancouver, British Columbia V6Z 1Y6, Canada
San Francisco, California 94143, United States
Gainesville, Florida 32610, United States
Atlanta, Georgia 30322, United States
Livingston, New Jersey 07039, United States
Philadelphia, Pennsylvania 19102-1192, United States
Saskatoon, Saskatchewan S7N 0W8, Canada
Charleston, South Carolina 29425-0777, United States
Falls Church, Virginia 22042-3300, United States
Additional Information
Starting date: December 2000
Last updated: August 17, 2015
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