Trial Information

Summary: Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant

Status: Completed

Protocol Number: ML18423

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus on preservation of renal function and prevention of acute rejection in recipients of an orthotropic liver transplant

Brief Summary: This 2 arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either Cellcept 1-1.5g bid + tacrolimus + cyclosporine or Cellcept 1-1.5 g bid + sirolimus.The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 340.

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: Liver Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil [CellCept]

Primary Outcome: 1. Superiority for calculated GFR Time frame: 12 months post-transplant 2. Non-inferiority of biopsy-proven acute rejection; graft survival. Time frame: Event driven 3. Patient survival Time frame: 12 months

Key Secondary Outcomes: 1. Acute rejection episode, biopsy-proven acute rejection, treatment for rejection, time to first acute rejection, incidence of treatment failure. Time frame: Event driven 2. AEs Time frame: Throughout study

Inclusion Criteria:

  • adult patients 18-74 years of age;
  • single primary liver transplant from a deceased donor;
  • CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours);
  • patients with hepatitis C-positive status may be entered if they have had an intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at the time of randomization. This is not required for patients negative for hepatitis C.

Exclusion Criteria:

  • liver allograft from a living donor or a split liver;
  • multiple organ transplant;
  • dialysis therapy for >14 days from transplantation to randomization;
  • history of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer);
  • previous sirolimus therapy.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 74 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: August, 2005

Trial Registration Date: 08/29/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Miami, FL 33136
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: August 20, 2008 at 2:17:24 PM


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