AGEING 1.0
Research type
Research Study
Full title
AGe-adapted benefits of Envarsus versus twice-daily tacrolimus ImmunosuppressioN druGs after kidney transplantation (AGEING) – a feasibility study
IRAS ID
250173
Contact name
Adnan Sharif
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Eudract number
2018-003254-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 11 days
Research summary
Kidney transplantation is the gold standard treatment for people with kidneys that no longer work well. Kidney transplantation leads to improved survival, better quality of life and is a cheaper alternative to expensive dialysis. However, the risk of complications due to the need for lifelong anti-rejection (immunosuppression) tablets increases with age and therefore we should consider changing these tablets for older adults to achieve a balance between risk and benefit.
Envarsus® (Chiesi Pharmaceuticals) is an slow-release tablet version of tacrolimus licensed for the prevention of rejection in both kidney and liver transplant patients. It has been developed using special drug delivery technology which enhances its absorption after swallowing and remains in the bloodstream for longer. As older adults are an increasing number of people with kidney failure wishing to have a kidney transplant, it is important for us to investigate whether this new once-a-day tablet version of tacrolimus is any different than the current twice-a-day version of tacrolimus. This study will be the first trial in kidney transplantation looking at using different anti-rejection treatments for older adults (this is called age-adapted immunosuppression) and the results of this feasibility study would guide us regarding the need to plan for a bigger study in the future.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
19/EM/0075
Date of REC Opinion
29 Apr 2019
REC opinion
Further Information Favourable Opinion