Trial Information

Summary: CLEAR study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants

Status: No longer recruiting

Protocol Number: ML18496

Sponsor: Hoffman-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the achievement of a mycophenolic acid therapeutic window during treatment with 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in patients with kidney transplants

Brief Summary: This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 140.

Study Phase: III

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. Proportion of patients achieving therapeutic window by Day 5

Key Secondary Outcomes: 1. Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6 Safety: Renal function, opportunistic infections, malignancies, and adverse events

Inclusion Criteria:

  • adult patients >=18 years of age;
  • recipients of a primary kidney transplant.

Exclusion Criteria:

  • positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;
  • positive for hepatitis C virus, with moderate or severe liver disease;
  • active malignancy or history of malignancy, excluding skin cancer (basal or squamous cell) that has been adequately treated;
  • need for maintenance corticosteroids for another condition.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2005

Trial Registration Date: 08/29/2005

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Halifax, NS, Canada, B3J 3G9
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: May 13, 2008 at 1:59:00 PM


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