ClinicalTrials.gov has posted results from the completed Phase 3 INFINITI study of dapagliflozin in kidney transplant recipients. Sponsored by University Health Network, Toronto, the study enrolled 52 participants, assigning 26 to dapagliflozin and 26 to placebo. Fifty-one participants completed the study. After 12 weeks, mean systolic blood pressure changed by −6.615 mmHg with dapagliflozin and −3.706 mmHg with placebo. These figures do not, by themselves, demonstrate superiority. Secondary outcomes included renal and metabolic measures and body weight. Mean measured GFR changed by −3.116 mL/min/1.73 m² with dapagliflozin and +0.370 with placebo. Fasting glucose changed by +0.146 versus +0.576 mmol/L; HbA1c by −0.112 versus −0.143 percentage points; urinary albumin-to-creatinine ratio by −3.250 versus −3.134 mg/mmol; and weight by −1.208 versus +0.706 kg. No deaths were reported. No serious adverse events were reported in the dapagliflozin arm. One serious lupus flare occurred in the placebo arm and was documented as preceding study-drug administration. The registry tables provide no comparative p-values or confidence intervals, so statistical superiority, efficacy, renal protection, cardiovascular benefit, or broader safety conclusions cannot be inferred from these numerical results alone.
Research & Studies
Registry Results Report Dapagliflozin Findings in Kidney Transplant Recipients
Registry results from the INFINITI study show numerical differences between dapagliflozin and placebo after 12 weeks, but the registry tables provide no comparative p-values or confidence intervals.
