Trial Information

Summary: A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

Status: Completed

Protocol Number: M67005

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: 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. Target sample size is 525.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Condition: Kidney Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil [CellCept]

Primary Outcome: 1. Renal function (as measured by GFR) Time frame: 12 months post-transplant

Key Secondary Outcomes: 1. Patient and graft survival Time frame: 12 months post-transplant 2. Proportion of patients with biopsy-proven rejection; treatment failure. Time frame: 6 and 12 months post-transplant 3. AEs, OIs, malignancies, deaths Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 04/16/2008

Link To Trial Results

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Trial listings updated: May 13, 2008 at 1:59:03 PM