Liver Transplant RecipientsNCT02482974
Conversion From Sirolimus to Everolimus in the Maintenance Treatment of Liver Transplant Recipients
An observational study of Liver Transplant Recipients, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Recipients
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with liver transplantation who switch from sirolimus to everolimus
Who may be able to join
- Patients older than 18 years
- Liver transplant recipients who switch from sirolimus to everolimus
Who cannot join
- Patients who refuse the everolimus switching
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conversion From Sirolimus to Everolimus in the Maintenance Treatment of Liver Transplant Recipients: A 1-year Observational Study
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.
Read the 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
- Keywords
- Liver transplantation, Everolimus, Sirolimus, Treatment outcome, Safety
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with advers events, biopsy-proven acute/chronic rejection, graft loss, or death from switching time to 48 weeks post-conversion.
Measured: 48 weeks
Secondary outcomes (7)
Laboratory follow-up (hematological)
It will include complete blood count (hemoglobin, hematocrit, leukocyte, and platelet)
Measured: At baseline and Weeks 12, 24, 36, and 48
Laboratory follow-up (hepatic)
It will include serum transaminases, alkaline phosphatase, γ-glutamyl transferase, bilirubin, and albumin
Measured: At baseline and Weeks 12, 24, 36, and 48
Laboratory follow-up (renal)
It will include serum creatinine, eGFR (MDRD and CKD-EPI), and electrolytes (sodium, potassium, calcium, magnesium, and phosphate)
Measured: At baseline and Weeks 12, 24, 36, and 48
Laboratory follow-up (metabolic)
It will include fasting glucose, cholesterol, and triglyceride.
Measured: At baseline and Weeks 12, 24, 36, and 48
Laboratory follow-up (24-hour urine creatinine clearance)
Measured: At baseline and Week 48
Laboratory follow-up (24-hour urine proteinuria)
Measured: At baseline and Week 48
Median dose of everolimus
The median dose of everolimus to reach the therapeutic range (3 - 8 ng/mL)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Turan, Ege University
- Investigators
- Ilker Turan, M.D., Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482974
- Sponsor's protocol ID
- 15-3.1/53
- Status last verified
- Dec 2016
- First submitted
- 19 Jun 2015
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion From Sirolimus to Everolimus in the Maintenance Treatment of Liver Transplant Recipients: A 1-year Observational Study
- ClinicalTrials.gov ID
- NCT02482974
- Acronym / sponsor ID
- 15-3.1/53
- Conditions
- Liver Transplant Recipients
- Keywords
- Liver transplantation, Everolimus, Sirolimus, Treatment outcome, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with liver transplantation who switch from sirolimus to everolimus
Key inclusion criteria (2 listed)
- Patients older than 18 years
- Liver transplant recipients who switch from sirolimus to everolimus
Key exclusion criteria (1 listed)
- Patients who refuse the everolimus switching
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Laboratory follow-up (hematological)
Time frame: At baseline and Weeks 12, 24, 36, and 48
Laboratory follow-up (hepatic)
Time frame: At baseline and Weeks 12, 24, 36, and 48
Laboratory follow-up (renal)
Time frame: At baseline and Weeks 12, 24, 36, and 48
Laboratory follow-up (metabolic)
Time frame: At baseline and Weeks 12, 24, 36, and 48
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker Turan, M.D. principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Recipients, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.