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

Liver Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118742
• Other study ID #: ML18423
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2005
• Last updated: July 30, 2010
• Start date: August 2005
• Est. completion date: December 2008

Study information

• Verified date: July 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This two-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 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• mycophenolate mofetil [CellCept]
1-1.5 g orally or intravenously twice daily
• Tacrolimus
As prescribed, for 12 months
• Cyclosporine
As prescribed, for 12 months
• Sirolimus
2-4 mg orally once daily for 9-11 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant	Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.	12 months posttransplant	No
Secondary	Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant	Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.	6 months posttransplant	No
Secondary	Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant	Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.	24 months posttransplant	No
Secondary	Change From Baseline in Creatinine Clearance	Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation	6, 12, and 24 months posttransplantation	No

External Links

•   Clinical Study Report Synopsis