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

Liver Transplant Recipients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482974
• Other study ID #: 15-3.1/53
• Status: Completed
• Phase: N/A
• First received: June 19, 2015
• Last updated: December 19, 2016
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years

• Liver transplant recipients who switch from sirolimus to everolimus

Exclusion Criteria:

• Patients who refuse the everolimus switching

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Transplant Recipients

Locations

Country	Name	City	State
Turkey	Ege University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with advers events, biopsy-proven acute/chronic rejection, graft loss, or death from switching time to 48 weeks post-conversion.		48 weeks	Yes
Secondary	Laboratory follow-up (hematological)	It will include complete blood count (hemoglobin, hematocrit, leukocyte, and platelet)	At baseline and Weeks 12, 24, 36, and 48	Yes
Secondary	Laboratory follow-up (hepatic)	It will include serum transaminases, alkaline phosphatase, ?-glutamyl transferase, bilirubin, and albumin	At baseline and Weeks 12, 24, 36, and 48	Yes
Secondary	Laboratory follow-up (renal)	It will include serum creatinine, eGFR (MDRD and CKD-EPI), and electrolytes (sodium, potassium, calcium, magnesium, and phosphate)	At baseline and Weeks 12, 24, 36, and 48	No
Secondary	Laboratory follow-up (metabolic)	It will include fasting glucose, cholesterol, and triglyceride.	At baseline and Weeks 12, 24, 36, and 48	Yes
Secondary	Laboratory follow-up (24-hour urine creatinine clearance)		At baseline and Week 48	Yes
Secondary	Laboratory follow-up (24-hour urine proteinuria)		At baseline and Week 48	Yes
Secondary	Median dose of everolimus	The median dose of everolimus to reach the therapeutic range (3 - 8 ng/mL)	48 weeks	No