NCT02482974

Conversion From Sirolimus to Everolimus in the Maintenance Treatment of Liver Transplant Recipients

Conversion From Sirolimus to Everolimus in the Maintenance Treatment of Liver Transplant Recipients: A 1-year Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the safety and efficacy of conversion of sirolimus to everolimus in the maintenance treatment of LT recipients. Patients will be monitored every 12 weeks after the switch of treatment for 48 weeks. The laboratory tests including hematological, renal, hepatic, and metabolic parameters will be performed at each visit. Twenty-four-hour urine creatinine clearance and proteinuria will be determined from a 24-hour urine collection at baseline and week 48.

Detailed description

Everolimus (EVL) and sirolimus (SRL), an antagonist of mammalian target of rapamycin, has been introduced into solid organ transplantation to either replace or reduce the dose of potentially nephrotoxic calcineurin inhibitors. Although not approved for liver transplantation (LT), SRL has still been used in several LT centers. After EVL was approved by FDA and the Ministry of Health in Turkey for use in LT recipients, SRL was converted to EVL in our institution. This study aims to determine the safety and efficacy of conversion of SRL to EVL in the maintenance treatment of LT recipients. Patients who switch from SRL to EVL will be monitored every 12 weeks after the switch of treatment for 48 weeks. Efficacy measure will be included any observation in terms of biopsy-proven acute/chronic rejection and graft or patient loss due to rejection. Safety evaluations will be included discontinuation of EVL and analyses of adverse events and grading laboratory abnormalities. Laboratory evaluations will be included hematological (CBC), renal (serum creatinine, estimated glomerular filtration rate \[eGFR; Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI)\], and electrolytes), hepatic (serum transaminases, alkaline phosphatase, γ-glutamyl transferase, bilirubin, and albumin), and metabolic parameters (fasting glucose, cholesterol, and triglyceride) at each visit. Twenty-four-hour urine creatinine clearance and proteinuria will be determined from a 24-hour urine collection at baseline and week 48. For patients who were on additional immunosuppressive treatments, those medications will also be continued.

Conditions

• Liver Transplant Recipients

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-06-26
• Last updated: 2016-12-21

Locations

1 site across 1 country: Turkey (Türkiye)