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: August 26, 2014
Last verified: August 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

  Show 36 Study Locations
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: August 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014