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

NCT ID: NCT02482974

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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

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Liver Transplant Recipients

Keywords

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Liver transplantation Everolimus Sirolimus Treatment outcome Safety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years
* Liver transplant recipients who switch from sirolimus to everolimus

Exclusion Criteria

* Patients who refuse the everolimus switching
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ilker Turan

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilker Turan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

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Ege University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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15-3.1/53

Identifier Type: -

Identifier Source: org_study_id