Study of Therapeutic Monitoring of CellCept (Mycophenolate Mofetil) After Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00087581
First received: July 12, 2004
Last updated: June 1, 2016
Last verified: June 2016
  Purpose
This 3 arm study will evaluate the efficacy and safety of various dosing regimens of CellCept combined with various dosing regimens of cyclosporine or tacrolimus in kidney transplantation patients. Patients will be randomized to one of 3 dosing regimens to receive concentration-controlled CellCept with reduced cyclosporine or tacrolimus, concentration-controlled CellCept with standard cyclosporine or tacrolimus, or fixed-dose CellCept (1g bid) with standard cyclosporine or tacrolimus. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Condition Intervention Phase
Kidney Transplantation
Drug: Cyclosporine or tacrolimus
Drug: mycophenolate mofetil [CellCept]
Phase 4

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 of Various Dosing Regimens of CellCept Combined With Various Dosing Regimens of Cyclosporine or Tacrolimus on Treatment Failure in Kidney Transplantation Patients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients experiencing treatment failure [ Time Frame: Within 12 months post-transplant ] [ Designated as safety issue: No ]
  • Renal allograft function (by GFR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 717
Study Start Date: July 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Cyclosporine or tacrolimus
Reduced
Drug: mycophenolate mofetil [CellCept]
Concentration-controlled
Experimental: 2 Drug: Cyclosporine or tacrolimus
Standard, as prescribed
Drug: mycophenolate mofetil [CellCept]
Concentration-controlled
Experimental: 3 Drug: Cyclosporine or tacrolimus
Standard, as prescribed
Drug: mycophenolate mofetil [CellCept]
1g po bid

  Eligibility

Ages Eligible for Study:   13 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female patients 13-75 years of age
  • single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
  • patient receiving first or second kidney transplant

Exclusion Criteria:

  • immunosuppressive therapy (except corticosteroid treatment) within previous 28 days for a first transplant and 3 months for a second transplant
  • history of malignancy in last 5 years (except successfully treated localized non-melanoma 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: NCT00087581

  Show 57 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: NCT00087581     History of Changes
Other Study ID Numbers: ML17225 
Study First Received: July 12, 2004
Last Updated: June 1, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 30, 2016