Transplant Trial Watch

The effect of oral melatonin on renal ischemia-reperfusion injury in transplant patients: A double-blind, randomized controlled trial.

Panah, F., Ghorbanihaghjo, A. et al. (2019).

Transplant Immunology; [record in progress].

This study aimed to determine the anti-inflammatory and anti-oxidative effects of melatonin on the complications of ischemia reperfusion injury (IRI) and the level of Klotho expression in these patients.

Patients were randomly assigned into placebo (n=20) or melatonin group (n=20) receiving the same dose of 3 mg/day.

40 kidney transplant patients from a cadaveric donor.

Outcomes assessed included, serum melatonin levels, inflammatory and oxidative stress factors, renal function biomarkers, and Klotho gene/protein expression. All outcomes were assessed at two different time-points: 24 hours prior to transplantation and at discharge from hospital.

24 hours post-transplantation.

CET Conclusions
Melatonin has anti-oxidant and anti-inflammatory properties. This small study from Iran investigates whether oral melatonin can reduce ischaemia-reperfusion injury after cadaveric renal transplantation. The authors find reductions in biomarkers of IRI, including NGAL, MDA and TNF-alpha. Whilst the study was randomized and blinded by use of a placebo, the exact mechanism of randomization and blinding (i.e. who was responsible for generating the placebo) is not clear. The results are certainly interesting, but larger studies will be required to see if these findings translate to improved clinical outcomes.

Jadad score

Data analysis
Strict intention-to-treat analysis

Allocation concealment

Trial registration
Iranian Registry of Clinical Trials - IRCT - IRCT201610203812N

Funding source
Non-industry funded