Kidney transplantation - prevention of rejection. MedDRA version: 20.0 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Envarsus
Product Name: Envarsus
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: tacrolimus monohydrate
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Research and Innovation, Nottingham University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) ABO compatible kidney transplants 2) Aged 6 to 17 years inclusive at the time of consent 3) Able to comply with study protocol including being able to take medication in capsule/tablet form 4) Currently on BD-tac 5)Patients must be at least 6 months post-transplant 6) Stable patients with stable tacrolimus trough levels and kidney function 7) Estimated GFR by Schwartz equation >30 ml/min/1.73m2 at the time of screening on the two most recent measurements at least 3 months prior to enrolment. 8) Patients must agree to use an adequate method of contraception for the duration of the whole study Are the trial subjects under 18? yes Number of subjects for this age range: 6 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1) Aged 5 or less; aged 18 or over 2) Unable to swallow tablets/capsules 3) Antibody (ABO or HLA) incompatible kidney transplants 4) Treatment for acute rejection within the last 6 months 5) Treatment with antibody therapy within the last 6 months 6) =2 episodes of biopsy proven acute rejection in the preceding year 7) Delta eGFR decline of >20% in the preceding 6 months 8) Non-adherence with tacrolimus medication 9) Patients who are pregnant or breastfeeding 10)Patients with hypersensitivity to the active substance or excipients of the IMPs (Adoport and Envarsus) and to other macrolides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This pilot study aims to provide dosing guidelines for the conversion of twice daily preparations of tacrolimus to Envarsus. To do this, we will compare pharmacokinetics of Envarsus to standard twice daily tacrolimus. The following values will be obtained: 1) Maximum concentration (Cmax) 2) Time to maximum concentration (Tmax) 3) 24 hour area under the curve (AUC) ;Secondary Objective: The secondary research questions are as follows: How well is Envarsus tolerated in children (what are the side effects)? What well is the kidney transplant working on Envarsus? How many patients have rejection? Are there any patients who died or lost their transplant? What is the metabolism of tacrolimus on Envarsus? ;Primary end point(s): Pharmacokinetic measurements of Envarsus compared to twice daily tacrolimus: 1) Maximum concentration (Cmax) 2) Time to maximum concentration (Tmax) 3) 24 hour area under the curve (AUC) ;Timepoint(s) of evaluation of this end point: Pharmacokinetic study will be done 1 month after conversion to Envarsus and after at least 1 week stable dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes 1) To assess the safety and tolerability of Envarsus 2) Delta estimated glomerular filtration rate (eGFR) after 6 months (eGFR measured using Schwartz formula) 3) Biopsy proven acute rejection (BPAR). Biopsies to diagnose rejection are standard of care in paediatric kidney transplantation. 4) Patient and graft survival 5) Ratio of tacrolimus level/daily dose (C/D);Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
United Kingdom
Outcome results
None listed