A Phase 3 study evaluating dapagliflozin in kidney transplant recipients completed its primary phase on 2024-08-30. The trial found that dapagliflozin reduced systolic blood pressure by a mean of -6.615 mmHg, compared to a mean reduction of -3.706 mmHg in the placebo group.
Background
The study investigated dapagliflozin, an SGLT2 inhibitor, in kidney transplant recipients (KTR). These patients included those with or without pre-existing type 2 diabetes (T2D) or post-transplant diabetes mellitus (PTDM).
Trial design
The randomized, double-blind, placebo-controlled Phase 3 study (NCT04965935) enrolled 52 kidney transplant recipients. The trial's objective was to compare dapagliflozin 10 mg oral tablet to a placebo in patients with or without pre-existing type 2 diabetes or post-transplant diabetes mellitus. The primary outcome was to determine if dapagliflozin was superior to placebo in the reduction of blood pressure in kidney transplant recipients.
Key results
The trial reported the following mean changes from baseline:
- Systolic Blood Pressure (SBP):
- Dapagliflozin Tablets: mean change of -6.615 mmHg (Standard Error: 2.084).
- Placebo Matching Dapagliflozin Tablets: mean change of -3.706 mmHg (Standard Error: 2.12).
- Fasting Plasma Glucose:
- Dapagliflozin Tablets: mean change of 0.146 mmol/l (Standard Error: 0.341).
- Placebo Matching Dapagliflozin Tablets: mean change of 0.576 mmol/l (Standard Error: 0.346).
- Glycated Hemoglobin (HbA1c):
- Dapagliflozin Tablets: mean change of -0.112 % of glycated hemoglobin (Standard Error: 0.115).
- Placebo Matching Dapagliflozin Tablets: mean change of -0.143 % of glycated hemoglobin (Standard Error: 0.117).
- Carotid-femoral Pulse Wave Velocity:
- Dapagliflozin Tablets: mean change of -0.046 m/s (Standard Error: 0.527).
- Placebo Matching Dapagliflozin Tablets: mean change of -0.72 m/s (Standard Error: 0.536).
- Systemic Vascular Resistance:
- Dapagliflozin Tablets: mean change of -76.577 dynes*sec/cm^5 (Standard Error: 83.311).
- Placebo Matching Dapagliflozin Tablets: mean change of 2.106 dynes*sec/cm^5 (Standard Error: 86.131).
- Measured GFR:
- Dapagliflozin Tablets: mean change of -3.116 mL/min/1.73 m^2 (Standard Error: 0.99).
- Placebo Matching Dapagliflozin Tablets: mean change of 0.37 mL/min/1.73 m^2 (Standard Error: 1.01).
What this means
The primary completion of this Phase 3 trial indicates 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. While other parameters like Fasting Plasma Glucose and Systemic Vascular Resistance also showed numerical differences between the groups, the trial's primary focus was on blood pressure reduction. These results suggest a potential benefit of dapagliflozin in managing blood pressure in this specific patient population, which includes individuals with or without diabetes post-transplant. Further analysis would be needed to determine statistical significance and the full clinical relevance of these findings.
Source
The information regarding the primary completion and results of this trial 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 2024-08-30 on clinicaltrials.gov.