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Completed

NCT Number: NCT00118742

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

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mycophenolate mofetil [CellCept]

Drug

1-1.5 g orally or intravenously twice daily

Tacrolimus

Drug

As prescribed, for 12 months

cyclosporine

Drug

As prescribed, for 12 months

sirolimus

Drug

2-4 mg orally once daily for 9-11 months

Primary outcomes

  1. Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant

    Time frame: 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 outcomes

  1. Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant

    Time frame: 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.

  2. Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant

    Time frame: 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.

  3. Change From Baseline in Creatinine Clearance

    Time frame: 6, 12, and 24 months posttransplantation

    Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 12, 2005
Registry last updated
Aug 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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