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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 \n

Proportion 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

Page last updated: August 23, 2015

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