Dapagliflozin and 54-week kidney function in kidney transplant recipients with post-transplant diabetes mellitus: a randomized controlled trial.

AIMS: To evaluate dapagliflozin effects on kidney function and safety in kidney transplant recipients with post-transplant diabetes mellitus (PTDM).

METHODS

In this single-center, prospective, open-label randomized trial, 68 participants were assigned 1:1 to dapagliflozin 10 mg daily plus standard care or standard care alone. Week-54 observed-data analyses included 27 participants per group; an intention-to-treat multiple-imputation sensitivity analysis included all randomized participants.

RESULTS

At week 54, the baseline-adjusted between-group eGFR difference was 6.81 mL/min/1.73 m2 (95 % CI, 1.68 to 11.94; P = 0.010) in the complete-case analysis and 6.05 mL/min/1.73 m2 (95 % CI, 0.99 to 11.11; P = 0.020) after multiple imputation. The estimate was attenuated after additional multivariable adjustment, with the 95 % CI including no difference. Serum magnesium declined less with dapagliflozin, whereas HbA1c and tacrolimus trough concentrations were similar. Observed adverse-event frequencies were similar between groups, although the trial was not powered to assess uncommon safety events.

CONCLUSIONS

Dapagliflozin showed an exploratory week-54 eGFR signal, but the estimate was sensitive to covariate adjustment and missing-data assumptions. This small trial does not establish a definitive clinically meaningful kidney benefit.