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Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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: 9/29/2008
Link to trial result
This trial was conducted at the following locations:Canada - Edmonton, AB
- Halifax, NS
- London, ON
- Montreal, QC
United States - Birmingham, AL
- Phoenix, AZ
- La Jolla, CA
- Los Angeles, CA
- San Diego , CA
- San Francisco, CA
- Denver, CO
- Jacksonville, FL
- Miami, FL
- Tampa, FL
- Atlanta, GA
- Chicago, IL
- New Orleans, LA
- Boston, MA
- Burlington, MA
- Detroit, MI
- Minneapolis, MN
- Rochester, MN
- St Louis, MO
- Newark, NJ
- Hawthorne, NY
- New York, NY
- Chapel Hill, NC
- Cleveland, OH
- Oklahoma City, OK
- Philadelphia, PA
- Nashville, TN
- Dallas, TX
- Houston, TX
- San Antonio, TX
- Richmond, VA
- Madison, WI
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