NCT05685394: Dare-Esrd

DApagliflozin Cardiovascular Effects on Patients at End-stage REnal Disease

Status unknown Phase 4 Last updated 14 November 2023

What this trial tests

Phase 4 trial testing Dapagliflozin in End-stage Kidney Disease in 80 participants. Status unknown.

Timeline

24 January 2023

Primary endpoint
1 November 2024

1 December 2024

Quick facts

Lead sponsor	University of Campinas, Brazil
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	24 January 2023
Primary completion	1 November 2024
Estimated completion	1 December 2024
Sites	1 location across Brazil

Drugs / interventions tested

• Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →

Conditions studied

• End-stage Kidney Disease — all drugs for End-stage Kidney Disease →

Sponsor

University of Campinas, Brazil

Who can join

Adults 18 to 75, any sex, with End-stage Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Treatment with sodium glucose co-transporter type 2 inhibitors (Sglt2i) reduced the incidence of cardiovascular death and hospitalization for heart failure by 29% in individuals with moderate chronic kidney disease. Recent observations found that beyond its effect on natriuresis, Sglt2i directly interacts with cardiomyocytes inducing improvement of myocardial function. This effect is not mitigated as glomerular filtration rate declines. Therefore, plausibly treatment with Sglt2i may attenuate heart failure in individuals end-stage kidney disease (ESKD) requiring dialysis, in whom cardiovascular disease remains the leading cause of death.

In this context, this project was designed to estimate the effect of dapagliflozin on myocardial function of dialysis subjects. Individuals with diagnosed ESKD on dialysis for at least 3 months, from both sexes, aged more than 18 years of age are eligible. Exclusion criteria are pregnant woman, hepatic failure, and known allergy to study medications. Eligible patients will be recruited from the Nephrology Division of the Clinics Hospital of the University of Campinas (Unicamp). The study was designed as a prospective, randomized, open-label, phase 4 clinical trial. Patients will be randomized, 1:1, for a 6-months treatment with either dapagliflozin 10mg/day (n=40) add to standard treatment or standard treatment alone (n=40). At the randomization visit, all patients will undergo a detailed interview and medical examination by the physician-researcher, echocardiogram and blood samples will be collected for further biochemical analysis and follow up visits will be scheduled every month for endpoints disclosure and medications dispensation until the end of study participation at the 6th month visit when echocardiogram and blood sample collection will be repeated.

Primary goal will be the difference between groups in mean change of NTproBNP levels during treatment. Secondary endpoints encompass the mean change in ejection fraction, e/e' ratio, global longitudinal and radial strain and indexed left ventricle mass. Changes in bone metabolsm and structure, assessed by serum levels of FGF-23 and α-Klotho, and changes in bone mineral density will be compared between groups as an exploratory analysis.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Is There a Role for SGLT2 Inhibitors in Patients with End-Stage Kidney Disease?
   Siddiqui R, Obi Y, Dossabhoy NR, Shafi T. · · 2024 · cited 15× · PMID 38913113 · DOI 10.1007/s11906-024-01314-3
2. SGLT2 inhibitors in hemodialysis or peritoneal dialysis patients: rationale and state-of-the art.
   Minutolo R, Ruotolo C, Conte G, Borrelli S. · · 2026 · cited 2× · PMID 41487902 · DOI 10.1093/ckj/sfaf350
3. Hypertension in Patients With End-Stage Kidney Disease Requiring Dialysis: Bridging the Divide Between Evidence and Practice.
   Mayeda L, Bansal N. · · 2026 · PMID 41603034 · DOI 10.1161/hypertensionaha.125.24344
4. Dapagliflozin cardiovascular effects on end-stage kidney disease (DARE-ESKD-2) trial: rationale and design.
   Barreto J, Martins M, Pascoa M, Medorima STK, et al · · 2023 · DOI 10.21203/rs.3.rs-3434207/v1