Transplant Trial Watch

The effect of the use of omeprazole versus famotidine on the kidney transplant function: a randomized controlled study.

Miedziaszczyk, M., et al.

Scientific Reports 2025; 15(1): 1805.


Aims
This study aimed to examine the role of omeprazole versus famotidine on kidney transplant function.

Interventions
Participants were randomised to receive either omeprazole or famotidine.

Participants
24 adult patients with stable kidney transplant.

Outcomes
The main outcomes of interest were tacrolimus concentrations, tacrolimus dosage and kidney transplant function.

Follow-up
3 years

CET Conclusions
This is an interesting study in renal transplantation that focuses on the interaction between proton pump inhibitors and cytochrome p450, with the potential effect on tacrolimus serum levels and renal function. The study was randomised, but not blinded and included a small population- no power calculation is presented. The analysis of the results is further weakened by the dropout rate (2 withdrew consent, 2 lost to follow up and 2 with rejection), which left only 10 in the omeprazole arm and 8 in the famotidine arm. Omeprazole was associated with a higher blood concentration of tacrolimus normalised for dose. Tacrolimus dosage was lower in years 2 and 3 compared to year 1 in both groups. There was no significant difference in GFR or serum creatinine comparing both groups, except for when looking at percentage variation after 3 years where there was a median fall of approximately 5% in the omeprazole group and a rise of approximately 9% in the famotidine group. In this small study famotidine did not affect the pharmacokinetics of tacrolimus levels and therefore may be an alternative to proton pump inhibitors in renal transplantation.

Trial registration
ClinicalTrials.gov - NCT05061303

Funding source
Non-industry funded