Trial Information

Summary: A Study of CellCept (Mycophenolate Mofetil) and Zenapax in Prevention of Acute Rejection in Heart Transplant Patients

Status: Completed

Protocol Number: ML17910

Sponsor: Roche Farma SA

Company Division: Pharmaceutical

Official Scientific Title: An open-label pilot study of Zenapax in combination with CellCept and sirolimus on the prevention of acute rejection in patients receiving a heart transplant at risk of impaired kidney function

Brief Summary: This study will evaluate the efficacy and safety of intravenous Zenapax in combination with oral CellCept and oral sirolimus in patients receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 44.

Study Phase: IV

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Heart Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil[CellCept]

Primary Outcome: 1. Efficacy: Proportion of patients experiencing a biopsy-proven acute rejection episode at end of study

Key Secondary Outcomes: 1. Safety; Adverse events, laboratory abnormalities, opportunistic infections, patient and graft survival, malignancies

Inclusion Criteria:

  • adult patients >=18 years of age;
  • single organ (heart) transplant recipients;
  • at risk for post-transplant renal dysfunction.

Exclusion Criteria:

  • previous organ transplant;
  • previous treatment with CellCept, Zenapax or sirolimus;
  • positive for human immunodeficiency virus (HIV) infection;
  • history of malignancy within the last 5 years, except localized and treated skin cancer, treated and without evident relapse.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 10/27/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Pamplona, Spain, 31008
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: September 2, 2008 at 2:12:34 PM


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