Conversion From Sirolimus to Everolimus in the Maintenance Treatment of Liver Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT02482974|
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : December 21, 2016
|Condition or disease|
|Liver Transplant Recipients|
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.
|Study Type :||Observational|
|Actual Enrollment :||66 participants|
|Official Title:||Conversion From Sirolimus to Everolimus in the Maintenance Treatment of Liver Transplant Recipients: A 1-year Observational Study|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
- Proportion of patients with advers events, biopsy-proven acute/chronic rejection, graft loss, or death from switching time to 48 weeks post-conversion. [ Time Frame: 48 weeks ]
- Laboratory follow-up (hematological) [ Time Frame: At baseline and Weeks 12, 24, 36, and 48 ]It will include complete blood count (hemoglobin, hematocrit, leukocyte, and platelet)
- Laboratory follow-up (hepatic) [ Time Frame: At baseline and Weeks 12, 24, 36, and 48 ]It will include serum transaminases, alkaline phosphatase, γ-glutamyl transferase, bilirubin, and albumin
- Laboratory follow-up (renal) [ Time Frame: At baseline and Weeks 12, 24, 36, and 48 ]It will include serum creatinine, eGFR (MDRD and CKD-EPI), and electrolytes (sodium, potassium, calcium, magnesium, and phosphate)
- Laboratory follow-up (metabolic) [ Time Frame: At baseline and Weeks 12, 24, 36, and 48 ]It will include fasting glucose, cholesterol, and triglyceride.
- Laboratory follow-up (24-hour urine creatinine clearance) [ Time Frame: At baseline and Week 48 ]
- Laboratory follow-up (24-hour urine proteinuria) [ Time Frame: At baseline and Week 48 ]
- Median dose of everolimus [ Time Frame: 48 weeks ]The median dose of everolimus to reach the therapeutic range (3 - 8 ng/mL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482974
|Izmir, Turkey, 35100|
|Principal Investigator:||Ilker Turan, M.D.||Ege University|