NCT02482974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

June 19, 2015

Last Update Submit

December 19, 2016

Conditions

Liver Transplant Recipients

Keywords

Liver transplantationEverolimusSirolimusTreatment outcomeSafety

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Laboratory follow-up (hematological)

    At baseline and Weeks 12, 24, 36, and 48

  • Laboratory follow-up (hepatic)

    At baseline and Weeks 12, 24, 36, and 48

  • Laboratory follow-up (renal)

    At baseline and Weeks 12, 24, 36, and 48

  • Laboratory follow-up (metabolic)

    At baseline and Weeks 12, 24, 36, and 48

  • Laboratory follow-up (24-hour urine creatinine clearance)

    At baseline and Week 48

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with liver transplantation who switch from sirolimus to everolimus

You may qualify if:

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

You may not qualify if:

  • Patients who refuse the everolimus switching

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

Study Officials

  • Ilker Turan, M.D.

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 26, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 21, 2016

Record last verified: 2016-12

Locations

TU(1)