2024-515542-16-03CompletedPhase 4
Personalized Use of Resources Study (PURE)
Stichting Amsterdam UMC1 site in 1 country25 target enrollmentStarted: January 17, 2025Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Stichting Amsterdam UMC
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who have a C/D ratio < 1.05 ng/mL×1/mg.
Study Overview
Brief Summary
The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who receive tacrolimus who need a relatively high dose of tacrolimus, a C/D ratio < 1.05
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 to 70 years, inclusive, with a stable renal function; b. Patients who are at least 6 months until five years after first transplantation, who are not immunized (PRA<5%), with therapeutic tacrolimus concentrations between 4-9 ng/L, who are on a stable tacrolimus dose (same dosage of Tacrolimus extended release for the last month), with a C/D ratio < 1.05 ng/mL×1/mg; c. Patients must provide written informed consent; and d. Patients of childbearing potential must agree to use highly effective methods of contraception during the study.
Exclusion Criteria
- •a. Patient received or is receiving treatment for acute rejection prior to initiation of study; b. Donor Specific antibody positivity and patients who are immunized (PRA≥5%); c. Chronic diarrhoea; d. Use of phenytoin, carbamazepine, phenobarbital, primidone, rifampin, caspofungin, erythromycin, clarithromycin, fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole, fluoxetine, fluvoxamine, sertraline, venlafaxine, mirtazapine, paroxetine, diltiazem, verapamil, or amiodarone; e. Thyroid dysfunction; f. Excessive use of caffeine (more than use of 5 IE daily); g. Excessive use of alcohol (more than 2 IE daily); or h. Patients who are pregnant.
Outcomes
Primary Outcomes
The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who have a C/D ratio < 1.05 ng/mL×1/mg.
The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who have a C/D ratio < 1.05 ng/mL×1/mg.
Secondary Outcomes
- To evaluate if the switch design of the study leads to a lower pill burden; - to evaluate if the LCPT switch leads to less side effects; - to evaluate if the LCPT switch leads to less variability in trough levels; - to evaluate if patients with CYP3A5*1 allele is a factor to consider when prescribing tacrolimus variants; and - to evaluate differences in Cmax, Tmax and 24hour AUC levels.
Investigators
drs Nienke Manson
Scientific
Stichting Amsterdam UMC
Study Sites (1)
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