HOT2
Heme arginate in transplantation study – a multi-centre blinded parallel-group randomised trial of heme arginate versus placebo to reduce delayed graft function in kidney transplant recipients.
The main aim of the trial is to determine whether Heme arginate (HA) treatment increases the number of kidney transplants that work immediately (reduce delayed graft function (DGF)). In a previous single centre study we gave HA to 20 kidney transplant patients in the first 24 hours after transplant, and showed that it may reduce kidney injury and is safe. We plan to conduct a large study recruiting 600 patients.
Chief Investigator: Prof Lorna Marson
Number and location of participating sites / geographical scope (by region/ country): 12-15 UK sites (renal transplant centres)
EudraCT number: 2018-000131-27
ISRCTN number: Clinical Trials.gov ref NCT03646344
Funder: Kidney Research UK (KRUK)
Start and End date
Of grant award: May 2019 – Jan 2021
Of recruitment: Mar 2019 – Dec 2020
Current status: Closed
Email: hot2@ed.ac.uk
Twitter account: @Hot2Trial
Trial Unblinding Information: The individual who administered the infusion to the participant will be unblinded and can be contacted if required. Alternatively there is an unblinded investigator who can be contacted (currently Ewen Harrison, RIE).
If you have participated in this study and would like to read how the study complies with UK GDPR, please click on this link:
Sponsor: ACCORD http://accord.scot/
Chief Investigator: Prof Lorna Marson, Transplant Unit, RIE, Lorna.Marson@ed.ac.uk
Trial management team: hot2@ed.ac.uk
Research nurse: Janice Davidson (Janice.Davidson@nhslothian.scot.nhs.uk); Jayne Black (jayne.black@nhslothian.scot.nhs.uk)
ECTU Involvement: Trial management, statistics, health economics, randomisation (via database), data management.
(UKCRC)