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Figure 1 | Trials

Figure 1

From: 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

Figure 1

OuTSMART flow diagram. *Randomisation is performed using the results of a recruit’s first screening test. Those with donor specific antibodies (DSA) undergo no further screening as part of the trial (but serum will be stored for analysis of human leukocyte antigen antibody profiles later). †Those initially HLA Ab– undergo routine screening every 8 months. There is no second randomisation. A recruit allocated to blinded standard care (group C) who becomes HLA Ab + (black lines) will remain in a standard care group (group A1 or A2). If in the unblinded standard care group (D), they will change to unblinded biomarker-led treatment care (group B1 or B2) (orange lines). ‡ The numbers in each group are those anticipated at the primary end point. Ab, antibodies; DSA, donor-specific antibodies; HLA, human leukocyte antigen; MMF, mycophenolate mofetil; tac, tacrolimus.

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