Trial Information

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

Status: No longer recruiting

Protocol Number: ML17140

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of withdrawal of cyclosporine or tacrolimus on renal function in kidney transplant recipients receiving CellCept plus corticosteroids

Brief Summary: This 2 arm study will recruit kidney transplant patients receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g bid) and corticosteroids. They will either be randomized to continue this regimen, or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function will be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 305.

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: Kidney Transplantation

Intervention Type: Drug

Intervention Name: mycophenolate mofetil [CellCept]

Primary Outcome: 1. Mean percentage change in GFR Time frame: 12 months post randomization

Key Secondary Outcomes: 1. Renal function and GFR. Time frame: 6, 12 and 24 months 2. Percentage of patients with late acute biopsy-proven rejection; time to first, and percentage of, acute biopsy-driven rejection episodes; graft loss, death. OIs, malignancies. Time frame: Event driven

Inclusion Criteria:

  • adult patients 18-75 years of age;
  • kidney transplant 30-180 days post-transplantation;
  • receipt of cyclosporine or tacrolimus, CellCept, and corticosteroids for greater than 14 days prior to study entry;
  • no known contraindications to sirolimus.

Exclusion Criteria:

  • multiple organ transplant recipients or secondary kidney transplant recipients;
  • corticosteroid-resistant rejection episode within 90 days prior to study entry or corticosteroid-sensitive rejection episode within 30 days prior to study entry;
  • more than 1 biopsy-proven episode of acute rejection prior to study entry;
  • treated with sirolimus before the study;
  • organ transplant or expected organ transplant, other than kidney;
  • history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer).

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: August, 2003

Trial Registration Date: 08/26/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
San Francisco, CA 94115
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 1:56:11 PM


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