Can a combined screening/treatment programme prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies: study protocol for the multicentre randomised controlled OuTSMART trial.
Dorling A, Rebolla-Mesa-I, et al.Trials. 2014; 15, 30.
Aims
A protocol to investigate the combination of HLA Ab screening and treatment to prevent premature failure of renal transplants due to chronic rejection.
Interventions
Patients will be randomised to blinded or unblinded screening arms. In the unblinded screening arm those patients with antibodies will have biomarker led care and administered prednisone, tacrolimus and mycophenolate mofetil. In the blinded arm participants will remain on their current therapy.
Participants
Renal transplant patients > one year post transplant aged 18-70 years with an estimated glomerular filtration rate (GFR) >30mL/min.
Outcomes
The primary outcomes will include the three year graft failure rate in HLA Ab+ patients. Secondary outcomes will include three year graft survival rates in all patients, patient survival, rate of progression of graft dysfunction, as assessed by the change in the degree of proteineuria (PCD>50) or the change in estimated GFR and rates of biopsy proven rejection at three years, rates of culture or polymerade chain reaction positive infection, biopsy proven malignancy, health economic analysis of outcomes and the analysis of adherence and perceptions of risk for the biomarker-care group.
Follow-up
1 year
CET Conclusions
This is a detailed protocol for a complex trial that will test several hypotheses. The outcomes are appropriate and well defined. The proposed method of randomisation is satisfactory and power calculations have been done for the primary analysis, which will be by intention to treat.
Quality notes
This is a protocol – quality assessment is not appropriate.
Trial registration
ISRCTN46157828