Caucasian paediatric kidney transplant recipients
Conditions
Interventions
Trade Name: Envarsus®
Pharmaceutical Form: Tablet
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0.75-4
Tr
Sponsors
University Hospital Essen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. caucasian paediatric kidney transplant recipients (single-organ recipients) 2. aged = 8 years but = 18 years who are under tacrolimus (Prograf®) therapy and who are able to swallow tablets with a minimum dose of 0.75 mg / day Envarsus® 3. not less than 6 months after transplantation 4. stable kidney function (delta GFR =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. coefficient of variation of tacrolimus trough level > 0.35 over the previous 6 months 2. pregnancy/breast feeding 3. instable kidney function 4. hypersensitivity to any of the components of the medications used. 5. patient is not eligible for any reason according to the investigator’s valuation 6. patient with known positive HIV-1 or HCV test 7. participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess, whether the tacrolimus full-area under the curve concentration with blood samples drawn before and 1.5, 2, 4, 6, 8, 12, 13.5, 14, 16, 20, 24 hrs after administration in compliant patients without any protocol deviations is bioequivalent between immediate-release tacrolimus (Prograf®) therapy and Envarsus®-therapy when a dose converting factor of 0.7 is used.;Secondary Objective: To assess efficacy in terms of residual expression of NFAT regulated genes (pharmacodynamics), potential influence of pharmacogenetics, trough levels and doses of prolonged-release tacrolimus (Envarsus®), the level of adherence, cumulative dosage and signs of tacrolimus toxicity and adverse events, biopsy proven rejections as well as a decrease in eGFR >10% of baseline and DSAs are determined.;Primary end point(s): Primary outcome variable / hypothesis: Full tacrolimus AUC over 24 hours under Envarsus® treatment (conversion factor 0.7) is 80-125% of the AUC of immediate-release tacrolimus (Prograf®). ;Timepoint(s) of evaluation of this end point: The Primary end point will be evaluated at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome variables for both study phases: pharmacodynamic analysis, pharmacogenetic analysis, conversion factor, tacrolimus trough levels, coefficient of variation of tacrolimus, number of dose adjustments, eGFR comparing the two study phases, cytokine/chemokine pattern (immunomonitoring), adverse events, treatment failure rate (composite endpoint: any patient who experienced death, graft failure, BPAR or lost to follow-up), limited sampling strategy (LSS) driven 24h-AUC estimation, NFAT expression, composition of gut microbial metabolism and its contribution to tacrolimus pharmacokinetics.;Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated at the end of the trial. | — |
Countries
Germany
Contacts
Public ContactStudy Coordination
Universitätsmedizin Essen - Studienzentrum GmbH
Outcome results
None listed