Transplant Renal Artery Stenosis: Observation versus Stenting (TRASOS)
Research type
Research Study
Full title
Transplant Renal Artery Stenosis Observation versus Stenting (TRASOS) study - an open label, randomised, controlled trial comparing stenting of transplant renal artery stenosis with no stenting of transplant renal artery stenosis
IRAS ID
273080
Contact name
Michelle Willicombe
Contact email
Sponsor organisation
Joint Research Compliance Office, Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 29 days
Research summary
Renal transplantation is the treatment of choice for most patients with end stage kidney disease (ESKD). According to the most recent annual report from the renal registry, 7959 adult patients started renal replacement therapy (RRT) for end stage kidney disease (ESKD) in the United Kingdom in 2018. 9.3% of these patients had a transplant within 90 days of developing ESKD. The prevalence of RRT among the adult population on the final day of 2018 was 66,612 patients. Of these patients, 55.7% (37,302) had a functioning renal transplant. Therefore, renal transplantation is the most common treatment modality for ESKD. Additionally, more kidney transplantations are being performed year on year, with a 5% increase in surgical activity in 2018 compared to 2017.\n\nThe average longevity of a renal transplant is fifteen years; a relatively static figure that has not improved in recent decades despite advances in immunosuppression.\n \nTransplant renal artery stenosis (TRAS) is a reportedly uncommon complication of renal transplantation with an average incidence of 2-3%. However, at Imperial College Renal and Transplant Centre (ICRTC), transplant recipients are relatively frequently screened for TRAS using magnetic resonance angiography (MRA). Consequently, the prevalence of TRAS within our centre is higher at 14%. \n\nOur hypothesis is that undergoing formal angiography and stenting of TRAS results in an improvement in transplant function at one year after the time of diagnosis of TRAS, compared with patients who receive non-interventional therapy alone. \n\nWe would recruit 36 patients with MRA confirmed TRAS, randomise them in a 2:1 fashion to the interventional arm (n=24) and active monitoring control arm (n=12) and follow them up over a 12-month period. The primary outcome measure would be change in estimated glomerular filtration rate (eGFR) at one year following TRAS diagnosis between the intervention group and the control group.\n
REC name
Wales REC 3
REC reference
20/WA/0343
Date of REC Opinion
15 Dec 2020
REC opinion
Favourable Opinion