Minimisation of Immunosuppression in renal Transplant Recipients
Research type
Research Study
Full title
A Randomised feasibility trial on the Minimisation of Immunosuppression In Elderly Renal Transplant Recipients
IRAS ID
1005447
Contact name
Alan Salama
Contact email
Sponsor organisation
University College London
Eudract number
2022-000051-36
ISRCTN Number
ISRCTN15218460
Clinicaltrials.gov Identifier
Research summary
Kidney transplantation provides the optimal form of kidney replacement therapy for the majority of people with end-stage kidney disease, and has now become the commonest form of kidney replacement therapy. However, donor and recipient demographics have changed considerably over the past few decades: increasingly older donor kidneys are transplanted into increasingly older recipients with greater comorbidities. Increasing age remains a major risk factor for death after kidney transplantation, with the commonest causes of deaths for recipients aged 70 and over being cardiovascular disease, infection, and malignancies. Immunosuppressant drugs which are critical for the maintenance of the transplanted organ can contribute to increased morbidity and mortality, by direct effects or through lowered immunity predisposing to infection. Cytomegalovirus (CMV) is one of the most common opportunistic infections that affects renal transplant patient outcome and can be monitored prospectively. Hence, minimising immunosuppression, especially in older recipients, may result in better graft and patient outcomes as many side-effects are dose dependant. However, to date drug doses have never been adjusted based on age, despite significant changes that occur to immune responsiveness as patients grow older. In addition we have not had a useful biomarker to help define appropriate immunosuppressive levels for each individual. We therefore aim to study the effect of reducing the target immunosuppression drug levels (of tacrolimus and mycophenolate) in kidney transplant recipients >60 years, using CMV viraemia as a main outcome measure, and investigating rates of rejection and development of de novo donor-specific anti-HLA antibodies. We will assess the clinical utility of donor-derived cell free DNA (dd-cfDNA) as a means to guide immunosuppression minimisation.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0389
Date of REC Opinion
5 Sep 2022
REC opinion
Further Information Favourable Opinion