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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048152
Recruitment Status : Completed
First Posted : October 25, 2002
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 539 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2000
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Renal function (as measured by GFR) [ Time Frame: 12 months post-transplant ]

Secondary Outcome Measures :
  1. Patient and graft survival \n [ 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048152

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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
Adelaide, Australia, 5011
Sydney, Australia, 2050
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
Vandoeuvre-les-nancy, France, 54511
Berlin, Germany, 13353
Hannover, Germany, 30625
Muenster, Germany, 48149
Mexico City, Mexico, 06720
Monterrey, Mexico, 06720
Oslo, Norway, 0027
Warszawa, Poland, 02-006
Wroclaw, Poland, 50-417
Barcelona, Spain, 08036
Barcelona, Spain, 08907
Córdoba, Spain, 14004
Malaga, Spain, 29010
Santander, Spain, 39008
Valencia, Spain, 46009
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
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT00048152    
Other Study ID Numbers: M67005
First Posted: October 25, 2002    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Calcineurin Inhibitors