Trial Information

Summary: A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients

Status: Completed

Protocol Number: PA16290

Sponsor: Hoffmann-La Roche Ltd/Inc/AG

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of CellCept, sirolimus, and corticosteroids with or without daclizumab on the pharmacokinetics of mycophenolic acid in renal transplant patients

Brief Summary: This study will assess the pharmacokinetics, safety and efficacy of CellCept in combination with Rapamune (sirolimus) or Neoral (Cyclosporine) when used in conjunction with Zenapax(daclizumab) and corticosteroids in patients undergoing kidney transplantation. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 45.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Condition: Kidney Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil[CellCept]

Primary Outcome: 1. MPA and MPAG blood concentrations; MPA and MPAG trough plasma concentrations

Key Secondary Outcomes: 1. Safety: Vital signs, laboratory analyses, AEs, OIs, malignancies, deaths. Efficacy: Acute rejection or treatment failure, time to first acute rejection, patient and graft survival

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:53:18 PM