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Trial record 12 of 883 for:    Liver Transplant

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
Sponsor:
Information provided by (Responsible Party):
Ilker Turan, Ege University

Brief 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.

Condition or disease
Liver Transplant Recipients

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.


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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. Laboratory follow-up (metabolic) [ Time Frame: At baseline and Weeks 12, 24, 36, and 48 ]
    It will include fasting glucose, cholesterol, and triglyceride.

  5. Laboratory follow-up (24-hour urine creatinine clearance) [ Time Frame: At baseline and Week 48 ]
  6. Laboratory follow-up (24-hour urine proteinuria) [ Time Frame: At baseline and Week 48 ]
  7. Median dose of everolimus [ Time Frame: 48 weeks ]
    The median dose of everolimus to reach the therapeutic range (3 - 8 ng/mL)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with liver transplantation who switch from sirolimus to everolimus
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who refuse the everolimus switching

Information from the National Library of Medicine

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


Locations
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Turkey
Ege University
Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Investigators
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Principal Investigator: Ilker Turan, M.D. Ege University

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Responsible Party: Ilker Turan, Assoc. Prof., Ege University
ClinicalTrials.gov Identifier: NCT02482974     History of Changes
Other Study ID Numbers: 15-3.1/53
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016

Keywords provided by Ilker Turan, Ege University:
Liver transplantation
Everolimus
Sirolimus
Treatment outcome
Safety

Additional relevant MeSH terms:
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Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents