Trial results for a Phase 3 study evaluating dapagliflozin in kidney transplant recipients were posted on ClinicalTrials.gov on 2026-06-08. The study found that dapagliflozin reduced systolic blood pressure by -6.615 mmHg compared to -3.706 mmHg with placebo.
Background
The study investigated dapagliflozin, an SGLT2 inhibitor, in kidney transplant recipients (KTR) with or without pre-existing type 2 diabetes (T2D) or post-transplant diabetes mellitus (PTDM).
Trial design
The Phase 3 study (NCT04965935) enrolled 52 participants identified as kidney transplant recipients with or without post-transplant diabetes mellitus or type 2 diabetes. This randomized, double-blind, placebo-controlled clinical trial compared dapagliflozin 10 mg oral tablet to a placebo matching dapagliflozin oral tablet. The primary outcome was to determine if dapagliflozin is superior to placebo in reduction of blood pressure in KTR.
Key results
Key measurements from the trial included:
- Systolic Blood Pressure (SBP): The dapagliflozin group showed a mean change of -6.615 mmHg (Standard Error: 2.084), while the placebo group showed a mean change of -3.706 mmHg (Standard Error: 2.12).
- Fasting Plasma Glucose: The dapagliflozin group had a mean change of 0.146 mmol/l (Standard Error: 0.341), compared to 0.576 mmol/l (Standard Error: 0.346) in the placebo group.
- Glycated Hemoglobin (HbA1c): The dapagliflozin group showed a mean change of -0.112 % of glycated hemoglobin (Standard Error: 0.115), versus -0.143 % of glycated hemoglobin (Standard Error: 0.117) in the placebo group.
- Carotid-femoral Pulse Wave Velocity: The dapagliflozin group had a mean change of -0.046 m/s (Standard Error: 0.527), while the placebo group showed a mean change of -0.72 m/s (Standard Error: 0.536).
- Systemic Vascular Resistance: The dapagliflozin group showed a mean change of -76.577 dynes*sec/cm^5 (Standard Error: 83.311), compared to 2.106 dynes*sec/cm^5 (Standard Error: 86.131) in the placebo group.
- Measured GFR: The dapagliflozin group had a mean change of -3.116 mL/min/1.73 m^2 (Standard Error: 0.99), versus 0.37 mL/min/1.73 m^2 (Standard Error: 1.01) in the placebo group.
What this means
The results indicate that dapagliflozin demonstrated a greater reduction in systolic blood pressure compared to placebo in kidney transplant recipients. Specifically, the mean reduction in SBP was -6.615 mmHg for dapagliflozin versus -3.706 mmHg for placebo. Other measurements, including fasting plasma glucose, glycated hemoglobin, carotid-femoral pulse wave velocity, systemic vascular resistance, and measured GFR, also showed changes, though the primary focus of the trial was on blood pressure reduction. These findings suggest a potential benefit of dapagliflozin in managing blood pressure in this specific patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04965935, titled "Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients", were posted on 2026-06-08 on clinicaltrials.gov.