Trial Information

Summary: A Study of the Effect of CellCept (Mycophenolate Mofetil) on Renal Function After Withdrawal of Cyclosporine in Kidney Transplant Patients

Status: Completed

Protocol Number: M55012

Sponsor: F Hoffman-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of CellCept on renal function after cyclosporine withdrawal in kidney transplant patients with deteriorating renal function

Brief Summary: This study will assess whether CellCept improves renal function following the withdrawal of cyclosporine in kidney transplant patients with deteriorating renal function. Following the core, treatment phase, a long-term observational follow-up phase will assess whether a treatment effect is maintained over time. The anticipated time on study treatment is >2 years, and the target sample size is <100 individuals. Target sample size is 79.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Kidney Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil[CellCept]

Primary Outcome: 1. Efficacy: Change in serum creatinine after withdrawal of cyclosporine

Key Secondary Outcomes: 1. Safety: Adverse events, opportunistic infections, malignancies

Inclusion Criteria:

  • adult male or female patients 18-65 years of age;
  • renal transplant >=15 months previously;
  • baseline biopsy and serum creatinine levels indicating deterioration of renal function within last 12 months;
  • patients receiving a cyclosporine-based immunosuppressant regime;
  • for follow-up phase: patients who completed the treatment phase of the study.

Exclusion Criteria:

  • current CellCept therapy, with cyclosporine or Prograf;
  • biopsy-proven acute rejection within 3 months 3 months prior to study entry;
  • female patients who are pregnant, breast-feeding or of childbearing potential, not willing to use reliable contraception during, or for 6 weeks following, conclusion of CellCept therapy;
  • patients simultaneously participating in another study, or who have participated in another study within 30 days of entry into the study;
  • for follow-up phase: patients who did not complete, or who switched therapy during, the treatment phase of the study.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 65 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Porto Alegre, Brazil, 90560-030
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: September 2, 2008 at 1:54:38 PM


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