Trial Information

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

Status: Completed

Protocol Number: ML17225

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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

Brief Summary: 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. Target sample size is 720.

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. Percentage of patients experiencing treatment failure Time frame: Within 12 months post-transplant 2. Renal allograft function (by GFR) Time frame: 12 months

Key Secondary Outcomes: 1. AEs Time frame: Throughout study

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)

Gender: Males or Females

Age Limits: Min: 13 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/26/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Jacksonville, FL 32216
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 1:56:12 PM


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