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The STN Study

The STN Study. Liver Spare the Nephron (STN) Study. Reference Hoffmann-la Roche. NCT00118742. Background

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The STN Study

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  1. The STN Study Liver Spare the Nephron (STN) Study Reference Hoffmann-la Roche. NCT00118742.

  2. Background This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with mycophenolate mofetil (MMF) and sirolimus in recipients of an orthotropic liver transplant.

  3. Aim To assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with MMF and sirolimus in recipients of an orthotropic liver transplant.

  4. Method Study design: The STN study was a randomized parallel, open-label trial. Study population: Patients were between 18 and 74 years of age, had a single primary liver transplant from a deceased donor, initiated with MMF+tacrolimus from the time of transplant (within 72 h). Patients with liver transplant from a live donor or a split liver, multiple organ transplant and history of malignancy are excluded. Treatment regimen: Patients will be randomized to receive either MMF 1–1.5 g twice daily (BID)+tacrolimus+cyclosporine, or mycophenolate mofetil 1–1.5 g BID+sirolimus. End point: The primary outcome is the mean percent change in the estimated glomerular filtration rate (GFR) by modification of diet in renal disease MDRD-6 (variables like serum creatinine, albumin, urea nitrogen, gender, age and ethnicity) variable equation at 12 months post-transplantation. The secondary end point was change in the GFR 6 months, 24 months post-transplant, change from base line creatinine clearance 6, 12, 24 months post-transplant.

  5. Result The patients in the group I MMF+tacrolimus/cyclosporine (CNI) showed 1.2% change in the GFR as compared to 19.7% change in the MMF+sirolimus group (Group II). Group I showed no significant increase in the GFR as compared to the 25% increase in the GFR showed in group II 6 month’s post-transplant. There was no increase in the creatinine clearance in the group II as compare to the 18%, 14% and 8% increase in the group II after 6, 12 and 24 months post-transplant, respectively.

  6. Conclusion The combination of MMF with tacrolimus showed better effects post-transplantation than MMF with sirolimus. Adverse effects of mycophenolate mofetil (MMF) and tacrolimus combination were lesser than the combination of MMF with sirolimus.

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