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

October 24, 2002
August 26, 2014
December 2000
March 2006   (final data collection date for primary outcome measure)
Renal function (as measured by GFR) [ Time Frame: 12 months post-transplant ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00048152 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: Corticosteroids
    As prescribed
  • Drug: Neoral
    Low dose (target trough level 50-100ng/mL)
  • Drug: Neoral
    Standard dose (target trough level 150-300ng/mL)
  • Drug: Zenapax
    2mg/kg iv first dose, then 1mg/kg every 2 weeks
  • Drug: mycophenolate mofetil [CellCept]
    1g po bid
  • Experimental: 1
    Interventions:
    • Drug: Corticosteroids
    • Drug: Neoral
    • Drug: Zenapax
    • Drug: mycophenolate mofetil [CellCept]
  • Experimental: 2
    Interventions:
    • Drug: Corticosteroids
    • Drug: Neoral
    • Drug: Zenapax
    • Drug: mycophenolate mofetil [CellCept]
  • Experimental: 3
    Interventions:
    • Drug: Corticosteroids
    • Drug: Neoral
    • Drug: mycophenolate mofetil [CellCept]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
539
March 2006
March 2006   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   France,   Germany,   Mexico,   Norway,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT00048152
M67005
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP