A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048152
First received: October 24, 2002
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and N eoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, an d the target sample size is 500+ individuals.


Condition Intervention Phase
Kidney Transplantation
Drug: Corticosteroids
Drug: Neoral
Drug: Zenapax
Drug: mycophenolate mofetil [CellCept]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Renal function (as measured by GFR) [ Time Frame: 12 months post-transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient and graft survival \n [ Time Frame: 12 months post-transplant ] [ Designated as safety issue: No ]
  • Proportion of patients with biopsy-proven rejection; treatment failure. [ Time Frame: 6 and 12 months post-transplant ] [ Designated as safety issue: No ]
  • AEs, OIs, malignancies, deaths [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 539
Study Start Date: December 2000
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Corticosteroids
As prescribed
Drug: Neoral
Low dose (target trough level 50-100ng/mL)
Drug: Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
Drug: mycophenolate mofetil [CellCept]
1g po bid
Experimental: 2 Drug: Corticosteroids
As prescribed
Drug: Neoral
Low dose (target trough level 50-100ng/mL)
Drug: Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
Drug: mycophenolate mofetil [CellCept]
1g po bid
Experimental: 3 Drug: Corticosteroids
As prescribed
Drug: Neoral
Standard dose (target trough level 150-300ng/mL)
Drug: mycophenolate mofetil [CellCept]
1g po bid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048152

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
San Francisco, California, United States, 94143
United States, Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, New Jersey
Livingston, New Jersey, United States, 07039
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19102-1192
United States, South Carolina
Charleston, South Carolina, United States, 29425-0777
United States, Virginia
Falls Church, Virginia, United States, 22042-3300
Australia
Adelaide, Australia, 5011
Sydney, Australia, 2050
Belgium
Bruxelles, Belgium, 1070
Leuven, Belgium, 3000
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Edmonton, Alberta, Canada, T6G 2R8
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
France
Vandoeuvre-les-nancy, France, 54511
Germany
Berlin, Germany, 13353
Hannover, Germany, 30625
Muenster, Germany, 48149
Mexico
Mexico City, Mexico, 06720
Monterrey, Mexico, 06720
Norway
Oslo, Norway, 0027
Poland
Warszawa, Poland, 02-006
Wroclaw, Poland, 50-417
Spain
Barcelona, Spain, 08907
Barcelona, Spain, 08036
Córdoba, Spain, 14004
Malaga, Spain, 29010
Santander, Spain, 39008
Valencia, Spain, 46009
Sweden
Goeteborg, Sweden, 41345
Malmoe, Sweden, 20502
United Kingdom
Birmingham, United Kingdom, B15 2TH
Glasgow, United Kingdom, G11 6NT
Leicester, United Kingdom, LE5 4PW
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048152     History of Changes
Other Study ID Numbers: M67005
Study First Received: October 24, 2002
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 29, 2014