Study to evaluate the efficacy and side effects of Envarsus in patients who had a kidney transplantatio

Phase 1

• Conditions: Kidney transplant immunosupression for patients with CYP3A5*1 gene variance; MedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2020-001101-22-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-24
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

a. Patients aged 18 to 70 years, inclusive, with a stable renal function.
b. Patients who are at least 6 months until two years after first transplantation, who are not immunized with therapeutic tacrolimus concentrations between 5-8 ng/L and on a stable tacrolimus dose with Tacrolimus-Extended-Release with a C/D ratio < 1.05 ng/mL×1/mg.
c. Patients must provide written informed consent.
d. Patients of childbearing potential must agree to use highly effective methods of contraception during the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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.
c. Chronic diarrhoea.
d. Use of protease inhibitors or miconazoles or sedatives.
e Thyroid dysfunction.
f. Psychiatric or neurological history or use of psychotropic drugs.
g.Use of Beta2-agonists or anti-epileptic drugs.
h. Excessive use of caffeine (more than use of 5 IE daily).
i. Excessive use of alcohol (more than 2 IE daily).
j. Patients who are pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective:<br>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.<br><br><br>;Secondary Objective: Secondary objectives:<br>- To evaluate if the switch design of the study leads to a lower pill burden;<br>- To evaluate if the tacrolimus switch leads to less side effects.<br>- To evaluate if the tacrolimus switch leads to less variability in trough levels.;Primary end point(s): The dose in mg of Tacrolimus-LCPT (envarsus) needed to reach adequate levels of tacrolimus trough levels in comparison with Tacrolimus-Extended-Release (advagraf).;Timepoint(s) of evaluation of this end point: After last patient, last visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - variability of trough levels;<br>- Cmax and Tmax;<br>- Subgroup analyse of patients in need of 15mg> of Tacrolimus-Extended-Release;<br>- C/D ratio<br>- 24hour AUC levels;<br>- side effects;<br>- differences in different ethnic groups;<br>- CYP3A5 genotypes.<br>;Timepoint(s) of evaluation of this end point: After last patient, last visit.