Text Size

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: May 23, 2013
Last verified: May 2013
History of Changes
  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: mycophenolate mofetil [CellCept]
Drug: Zenapax
Drug: Neoral
Drug: Corticosteroids
 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:

U.S. FDA Resources

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: mycophenolate mofetil [CellCept]
1g po bid
Drug: Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
Drug: Neoral
Low dose (target trough level 50-100ng/mL)
Drug: Corticosteroids
As prescribed
Experimental: 2 Drug: mycophenolate mofetil [CellCept]
1g po bid
Drug: Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
Drug: Neoral
Low dose (target trough level 50-100ng/mL)
Drug: Corticosteroids
As prescribed
Experimental: 3 Drug: mycophenolate mofetil [CellCept]
1g po bid
Drug: Neoral
Standard dose (target trough level 150-300ng/mL)
Drug: Corticosteroids
As prescribed

  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
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: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
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 May 23, 2013