Hemin Preconditioning Upregulates Heme Oxygenase-1 in Deceased Donor Renal Transplant Recipients: A Randomized, Controlled, Phase IIB Trial.
Thomas RAB, Czopek A, et al.Transplantation 2016; 100(1): 176-183.
Aims
To evaluate heme arginate (HA) effect on heme oxygenase-1 (HO-1) upregulation after deceased donor kidney transplantation.
Interventions
Participants were randomized to receive either 3mg/kg HA diluted in 100 mL 0.9% NaCl, or placebo (100 mL 0.91% NaCl) given preoperatively on day 0 and again on day 2.
Participants
40 patients on the renal transplant waiting list
Outcomes
The primary outcome measured was HO-1 upregulation. Secondary outcomes were graft HO-1 upregulation and injury, urinary biomarkers and renal function.
Follow-up
7 days
CET Conclusions
The HOT study is a pilot study investigating the role of Heme Arginate (HA) in upregulating heme oxygenase-1 (HO-1) in renal transplant recipients. HO-1 may have an important role to play in reducing ischaemia-reperfusion injury. 40 recipients were randomised to receive HA or placebo post-transplant. HA successfully upregulated HO-1 in these patients, although no difference in clinical outcome (histological injury or renal function) were seen. These results demonstrate that upregulating HO-1 in the clinical setting is feasible and appears safe. The study was not powered to demonstrate a difference in clinical outcomes, so the results of future larger studies will be interesting to watch out for.
Data analysis
Per protocol analysis
Trial registration
EudraCT - 2011-004311-23; Clinicaltrials.gov - NCT01430156