Pilot dose conversion study of Envarsus in pediatric kidney transplant
Research type
Research Study
Full title
Pilot dose conversion study of extended release tacrolimus, Envarsus from standard twice daily tacrolimus in paediatric renal transplant recipients.
IRAS ID
252138
Contact name
Jon Jin Kim
Contact email
Sponsor organisation
Research and Innovation, Nottingham University Hospital
Eudract number
2018-003595-13
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
In kidney transplantation, children and young adults take the medicine known as tacrolimus which prevents the body from rejecting the new kidney. The uptake of tacrolimus in the body is poor and can be affected when taken with food. Therefore the dose of tacrolimus taken by each patient is different and all patients have their tacrolimus levels checked frequently to make sure they are getting the right dose. There are currently different types of tacrolimus on the market. Envarsus is a new type of tacrolimus (and the treatment that will be taken in this research study). It is an extended release version of tacrolimus (extended release means- it takes longer to leave the body as the medicine is released slowly). It is better absorbed throughout the gut and is only taken once a day. Envarsus is currently only used in adult patients over the age of 18. Therefore we would like to check that Envarsus can also be used in children and young adults.
The main aim of this study is to measure how well Envarsus is taken by the body and compare it to standard twice daily tacrolimus (Adoport). Additionally we would also like to make sure that the side effects experienced whilst taking Envarsus are less than the ones experienced whilst taking Adoport and also monitor how well the kidney transplant is working.
Summary of study results:
Tacrolimus is one of the main medications used to prevent rejection in kidney transplantation. Five paediatric patients completed this study and switched from twice daily tacrolimus (BD-tac) to extended release tacrolimus (LCP-tac). The absorption of LCP-tac was better and patients only needed 60% of the total daily BD-tac dose. We checked the blood concentration of tacrolimus at multiple time points over 24 hours. Similar to adult studies, paediatric patients taking LCP-tac had lower peak concentrations and the maximum level was achieved more gradually and later, consistent with a slow release profile. There was no difference in clinical outcomes (including rejection, kidney transplant function or side effects). LCP-tac is only taken once a day and can be an alternative to BD-tac in paediatric patients.
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0126
Date of REC Opinion
1 Oct 2019
REC opinion
Further Information Favourable Opinion