The Phase 3 clinical trial (NCT05321706) investigating dapagliflozin for renal protection in heart transplant recipients completed its primary phase on April 30, 2026. This milestone marks the completion of data collection for the study's primary outcomes, as reported on ClinicalTrials.gov.
Background
Kidney failure is a common and significant complication in heart transplant recipients, contributing substantially to morbidity and mortality. Dapagliflozin is an SGLT2 inhibitor, a class of drugs initially developed for diabetes treatment. These inhibitors have demonstrated benefits beyond glycemic control, including reducing adverse cardiovascular outcomes and protecting renal function in both diabetic and non-diabetic populations. The current trial addresses a gap in research, as SGLT2 inhibitors have not been previously tested in clinical trials specifically involving heart transplant recipients.
Trial design
The DAPAgliflozin for Renal Protection in Heart Transplant Recipients (DAPARHT) study (NCT05321706) is a Phase 3 clinical trial. It has an estimated enrollment of 430 participants. The study is investigating dapagliflozin in individuals with conditions including Heart Transplant Failure and Kidney Failure. Participants are assigned to receive either dapagliflozin 10 mg or a placebo. The trial aims to assess the effect of dapagliflozin in preventing deteriorating renal function in heart transplant recipients.
What this means
The primary completion of the DAPAgliflozin for Renal Protection in Heart Transplant Recipients trial signifies a crucial step towards understanding the potential role of dapagliflozin in this vulnerable patient population. While specific results are not yet available, the completion of the primary phase indicates that data collection for the main outcomes has concluded. Future data releases from this Phase 3 study will provide insights into whether dapagliflozin can offer renal protection to heart transplant recipients, potentially addressing a significant unmet medical need.
Source
Information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05321706, titled "DAPAgliflozin for Renal Protection in Heart Transplant Recipients," was posted with a primary completion date of April 30, 2026, on clinicaltrials.gov.