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

Phase 4

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: mycophenolate mofetil [CellCept]; Drug: Tacrolimus; Drug: Sirolimus; Drug: Cyclosporine

• Registration Number: NCT00118742
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-11
• Study First Posted: 2005-07-12
• Study Start: 2005-08
• Primary Completion: 2008-07
• Study Completion: 2008-12
• Results First Submitted: 2009-05-13
• Results First Submitted QC: 2010-02-19
• Results First Posted: 2010-03-10
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-30
• Last Update Posted: 2010-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CellCept + CNI (tacrolimus or cyclosporine)	mycophenolate mofetil [CellCept]	-
CellCept + CNI (tacrolimus or cyclosporine)	Tacrolimus	-
CellCept + sirolimus	mycophenolate mofetil [CellCept]	-
CellCept + CNI (tacrolimus or cyclosporine)	Cyclosporine	-
CellCept + sirolimus	Sirolimus	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant	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.
Change From Baseline in Creatinine Clearance	6, 12, and 24 months posttransplantation	Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation
Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant	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.