|
|
 |
|
 |
|
Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:United States - Bakersfield, CA
- Los Angeles, CA
- Palo Alto, CA
- Riverside, CA
- San Diego , CA
- San Francisco, CA
- Denver, CO
- Hartford, CT
- Washington, DC
- Atlanta, GA
- Maywood, IL
- Indianapolis , IN
- Iowa City, IA
- Lexington, KY
- New Orleans, LA
- Baltimore, MD
- Boston, MA
- Detroit, MI
- Camden, NJ
- Livingston, NJ
- New York, NY
- Durham, NC
- Cincinnati, OH
- Portland, OR
- Philadelphia, PA
- Charleston, SC
- Sioux Falls, SD
- Memphis , TN
- Nashville, TN
- Dallas, TX
- San Antonio, TX
- Charlottesville, VA
|
|
 |
|
