NCT03256864

A Six-month, Prospective, Single-center, Pilot Study Determining the Pharmacokinetics and Effectiveness of Twice-daily Tacolimus and Everolimus Regimen Convert to Once-daily Tacrolimus and Everolimus Regimen in Liver Transplant Patients

Completed Phase 4 Last updated 4 June 2020

What this trial tests

Phase 4 trial testing Tacrolimus and Everolimus in Liver Transplantation in 10 participants. Completed in 30 May 2020.

Timeline

1 January 2016

Primary endpoint
30 June 2019

30 May 2020

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	10
Start date	1 January 2016
Primary completion	30 June 2019
Estimated completion	30 May 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• Tacrolimus and Everolimus — full drug profile →

Conditions studied

• Liver Transplantation — all drugs for Liver Transplantation →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 18 to 65, any sex, with Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To evaluate pharmacokinetic profile of everolimus and tacrolimus in liver transplant recipients on AUC (area under the curve)
  Time frame: 6 month
  Area under the plasma concentration versus time curve (AUC)

Sponsor's own description

It has been identified that nonadherence to immunosuppressant regimen may cause long-term graft failure and death in solid organ transplant recipients. Therefore, simplification of the immunosuppression regimen by reducing daily dosing frequency may improve long-term outcome. The investigators will examine pharmacokinetics and safety profiles of stable liver transplant recipients receiving twice-daily TAC with EVR (BID) regimen and then being converted to once-daily TAC with EVR (QD) regimen over a 6-month study period post-conversion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.