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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.
 
ClinicalTrials.gov Identifier: NCT00048152
Recruitment Status : Completed
First Posted : October 25, 2002
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 24, 2002
First Posted Date  ICMJE October 25, 2002
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE December 2000
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2008)
Renal function (as measured by GFR) [ Time Frame: 12 months post-transplant ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplantation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2008)
539
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Mexico,   Norway,   Poland,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00048152
Other Study ID Numbers  ICMJE M67005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

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