MAESTRO
Research type
Research Study
Full title
Management strategies and clinical outcomes associated with cytomegalovirus (CMV) disease prevention in renal transplant patients in the UK (MAESTRO).
IRAS ID
293215
Contact name
Sunil Daga
Contact email
Sponsor organisation
Merck Sharp and Dohme (UK) Ltd
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
Cytomegalovirus (CMV) is a common infection carried by over 50% of people but it normally has no impact. However, when patients receive a transplant, such as a kidney transplant, they are at increased risk of CMV infection. This is because the transplant procedures requires patients to take drugs that suppress their immune system. Patients are at particular risk if the organ donor is positive for CMV and the person receiving the organ is negative for CMV, labelled as D+/R-. If CMV develops, patients are at risk of complications including transplant rejection or even death.
Treatment strategies are used to try and prevent CMV disease using drugs known as antivirals. There are two main approaches - prophylaxis treatment and pre-emptive therapy. With pre-emptive therapy, patients are regularly monitored and if the virus is detected, antiviral treatment is started as soon as possible. In contrast, prophylaxis treatment involves prescribing antiviral treatment regardless of whether there are signs of CMV. There are pros and cons of these approaches. For example, drugs costs are high with prophylaxis treatment but pre-emptive therapy means patients have frequent consultations so that they can be monitored.
The best approach for different patients is unclear. Guidance documents have been published but it is expected that there is a lot of variation in how clinics approach this challenge. A review of current standard of care and how this impacts patient outcomes and NHS resources would allow areas of improvement to be identified. This is the focus of this study and kidney transplant patients are of interest.
A medical chart review will be conducted to examine the treatment approach taken for high risk D+/R- patients. In addition, a site level/ physician survey will be conducted (1 per participating hospital) to get a broader and more general overview of their typical treatment approach.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0097
Date of REC Opinion
12 May 2021
REC opinion
Favourable Opinion