Safety and Tolerability of Sotagliflozin Among Kidney Transplant Recipients.
McGrath, M. M., et al.Transplantation. 2025 Dec 1;109(12):1887-1895.
Aims
This study aimed to investigate the role of a sodium-glucose cotransporter inhibitor (SGLTi), Sotaglifozin, in stable kidney transplant recipients.
Interventions
Participants were randomised to receive either unlimited access to estimated glomerular filtration rate (eGFR) measurements or limited access to eGFR measurements
Participants
40 stable adult kidney transplant recipients.
Outcomes
The primary endpoint was the reversibility of eGFR changes. The main secondary endpoint was the proportion of patients who successfully completed the full treatment protocol.
Follow-up
CET Conclusions
SGLT inhibitors have been shown to reduce progression of CKD and need for dialysis/transplantation but have not been widely studied in the kidney transplant population. Use of SGLT inhibitors is associated with an initial decline in eGFR from baseline, which may be a concern in kidney transplant recipients and affect compliance. This small single-centre study explores the use of the SGLT inhibitor Sotaglifozin in 50 stable renal transplant recipients at least 1-year post-transplant. 71% patients approach declined to participate. All patients received the drug, and the clinical team were randomised to have all eGFR measurements available, or to only be informed if the eGFR dropped >25% from baseline. The mean change in eGFR from baseline was -4.6ml/min, and this partially reversed when the drug was stopped after 12 weeks. Access to eGFR measurements did not affect compliance with the drug, and no patients had the drug withdrawn due to eGFR changes. The results provide some useful insights to the feasibility of a larger efficacy trial of SGLT inhibitors in the renal transplant population. Low consent rates may make recruitment challenging, but for those patients who consent compliance is good and the average fall in eGFR relatively small and of limited clinical significance.
Data analysis
Strict intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT05405556