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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:
ClinicalTrials.gov Identifier:
NCT00048152
First Posted: October 25, 2002
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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 Intervention Phase
Kidney Transplantation Drug: Corticosteroids Drug: Neoral Drug: Zenapax Drug: mycophenolate mofetil [CellCept] Phase 3

Study Type: Interventional
Study Design: 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

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 ]

Secondary Outcome Measures:
  • Patient and graft survival \n [ Time Frame: 12 months post-transplant ]
  • Proportion of patients with biopsy-proven rejection; treatment failure. [ Time Frame: 6 and 12 months post-transplant ]
  • AEs, OIs, malignancies, deaths [ Time Frame: Throughout study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00048152


  Show 36 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048152     History of Changes
Other Study ID Numbers: M67005
First Submitted: October 24, 2002
First Posted: October 25, 2002
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Mycophenolic Acid
Cyclosporine
Cyclosporins
Daclizumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors