Kidney transplant immunosupression for patients with CYP3A5*1 gene variance MedDRA version: 20.0 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Tacrolimus LCPT
Product Name: Envarsus
Product Code: L04AD02
Pharmaceutical Form: Tablet
INN or Proposed INN: Envarsus
CAS Number: 109581-93-3
Current Sponsor code: L04AD02
Other descripti
Sponsors
Amsterdam UMC
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: 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. ;Secondary Objective: Secondary objectives: - To evaluate if the switch design of the study leads to a lower pill burden; - To evaluate if the tacrolimus switch leads to less side effects. - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - variability of trough levels; - Cmax and Tmax; - Subgroup analyse of patients in need of 15mg> of Tacrolimus-Extended-Release; - C/D ratio - 24hour AUC levels; - side effects; - differences in different ethnic groups; - CYP3A5 genotypes. ;Timepoint(s) of evaluation of this end point: After last patient, last visit. | — |
Countries
Netherlands
Contacts
Public ContactDr. N. Manson
Amsterdam UMC
Outcome results
None listed