This is a blinded, placebo-controlled, randomised controlled trial looking at the effects of Heme arginate (HA) on cadaveric renal transplantation. The investigators know that HA can upregulate HO-1, which has been shown to have a protective effect on animal transplants. The investigators will be giving HA/placebo to participants prior to transplant and repeat again on day 2 post-transplant and compare outcomes.
Patients will be recruited from the East of Scotland transplant waiting list and consent when they arrive in the hospital. The investigators will randomise them to drug or placebo and give the infusion prior to induction for their transplant. A blood sample will be taken prior to infusion and a renal biopsy will be taken before the graft is implanted. These will be used as baseline values. Patients will receive standard care from our unit. The investigators will use the routine blood test results (urea and creatinine) to determine the function of the graft. The investigators will take blood samples 24 hours after infusion of drug/placebo and use this to determine the primary outcome. Blood tests will be taken daily and a renal biopsy taken on day 5 to fulfil secondary objectives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
40
3mg/kg as a single IV infusion prior to transplant over 30 mins and same dose repeated on day 2 post-transplantation. Each drug infusion will be followed by 100ml saline IV to flush the line.
Solution for infusion, this will be given prior to transplantation and again on day 2; the same as active drug.
Royal Infirmary of Edinburgh/ University of Edinburgh
Edinburgh, Lothian, United Kingdom
Macrophage/monocyte HO-1 protein levels
We will measure the level of HO-1 protein in isolated macrophages/ monocytes in a peripheral blood sample taken at 24 hours after drug infusion
Time frame: 24 hours
Macrophage/monocyte HO-1 mRNA levels
We will measure HO-1 mRNA levels in macrophages/monocytes from a peripheral blood sample taken at 24 hours.
Time frame: 24 hours
HO-1 protein in kidney transplant
We will measure the level of HO-1 protein in kidney tissue from a biopsy sample taken 5 days after drug infusion. This will be compared to baseline
Time frame: 5 days
Effect on transplanted kidney function
We will record how the kidney functions by determining presence or absence of delayed graft function.
Time frame: daily for 5 days
Urinary biomarkers as markers of injury
We will collect urine to measure the presence of specific urinary biomarkers and correlate with renal function.
Time frame: daily for 5 days
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