NCT05343078 (DARE-ESKD 1) is a Phase 4 clinical trial of Dapagliflozin 10Mg Tab in End-stage Renal Disease, sponsored by University of Campinas, Brazil.

Who is sponsoring NCT05343078?

NCT05343078 is sponsored by University of Campinas, Brazil.

What drugs are being tested in NCT05343078?

Interventions in NCT05343078: Dapagliflozin 10Mg Tab.

What condition does NCT05343078 study?

NCT05343078 studies End-stage Renal Disease.

Is NCT05343078 still recruiting?

NCT05343078 is currently completed. Last updated 9 March 2023.

Last reviewed 2023-03-09 · How we verify

NCT05343078: DARE-ESKD 1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetics and Dialyzability of Dapagliflozin in Dialysis Patients

Completed Phase 4 Last updated 9 March 2023

What this trial tests

Phase 4 trial testing Dapagliflozin 10Mg Tab in End-stage Renal Disease in 5 participants. Completed in 1 October 2022.

Timeline

25 April 2022

Primary endpoint
1 September 2022

1 October 2022

Quick facts

Lead sponsor	University of Campinas, Brazil
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	25 April 2022
Primary completion	1 September 2022
Estimated completion	1 October 2022
Sites	1 location across Brazil

Drugs / interventions tested

Dapagliflozin 10Mg Tab — full drug profile →

Conditions studied

End-stage Renal Disease — all drugs for End-stage Renal Disease →

Sponsor

University of Campinas, Brazil

Who can join

18 and older, any sex, with End-stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sodium-glucose co-transporter 2 inhibitors (Sglt2i) attenuate the incidence of cardiovascular events in individuals with preserved or mildly reduced kidney function. Whether this benefit is also observed among individuals with end-stage renal disease (ESRD), in whom cardiovascular disease is a leading cause of mortality, remains unexplored. To appraise the influence of dialysis on the pharmacokinetics of Sglt2i is a prerequisite to determining the treatment regimen that best fits this population. In this study ESRD individuals, aged 18 years and older, on a regular dialysis regimen for a minimum of 3 months at the Nephrology Division of the Clinics Hospital of the University of Campinas (Unicamp) will be enrolled in a pharmacokinetics study. In the single-dose protocol, hemodialysis participants will take Dapagliflozin 10mg P.O. immediately before the dialysis session, and blood samples will be collected every 30min during dialysis and again 24h and 48h after termination. The dialysate will be continuously sampled in a tank and aliquots collected for further analysis. In the multiple-dose protocol, both hemodialysis and peritoneal dialysis participants will take Dapagliflozin 10mg P.O. daily in the morning for 7 days. Blood samples will be collected at baseline, and again after 48h and 7 days. The plasma levels of dapagliflozin and its inactive metabolite, D3OG, will be calculated from blood and dialysate samples using liquid chromatography mass spectrometry. The primary outcome is the plasma concentration-time curve of dapagliflozin and its inactive metabolite D3OG during a regular hemodialysis session. Secondary outcomes are: (i) the steady-state plasma concentration of Dapa; (ii) the accumulation ratio of Dapa; (iii) the total mass of Dapa and D3OG extracted by the dialysate; (iv) the dialytic clearance of dapagliflozin.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacokinetic Properties of Dapagliflozin in Hemodialysis and Peritoneal Dialysis Patients.
Barreto J, Borges C, Rodrigues TB, Jesus DC, et al · · 2023 · cited 26× · PMID 37227937 · DOI 10.2215/cjn.0000000000000196

Verify or expand the search:

Other trials of Dapagliflozin 10Mg Tab

Trials testing the same drug.

NCT04930549 — Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC) · Phase 2 · completed
NCT05254626 — Efficacy and Safety of Dapagliflozin in Patients with Non-alcoholic Steatohepatitis · Phase 2 · completed
NCT05335629 — Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients · NA · completed
NCT05268926 — TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension · Phase 2 · terminated
NCT05141552 — The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure · NA · unknown

Other recruiting trials for End-stage Renal Disease

Currently open trials in the same condition.

NCT06755372 — The Role of Toll-like Receptor-4 in Periodontitis Patients With End-stage Renal Disease in a Sample of Egyptian Populati · recruiting
NCT05473299 — Xeltis Hemodialysis Access Graft: aXess Pivotal Study · NA · active not recruiting
NCT05154773 — Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication · NA · active not recruiting
NCT03994497 — Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Rena · NA · recruiting
NCT02728817 — Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation · NA · active not recruiting

Other University of Campinas, Brazil trials

Trials by the same sponsor.

NCT06929676 — Assessment of Tooth Mobility After Non-surgical Periodontal Treatment Followed by Tooth Splinting · NA · enrolling by invitation
NCT07456163 — Influence of Zirconia Abutments on Peri-Implant Tissues in Single-Tooth Restorations · NA · recruiting
NCT06884475 — Evaluation of Implantoplasty in the Treatment of Peri-Implantitis. · NA · active not recruiting
NCT06450327 — Resistant Hypertension An Open, Complicated ("Cum Plicare") or Complex ("Cum Plexus") Syndrome? · recruiting
NCT06600867 — Method for Measuring Dental Mobility and Displacement Force · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05343078 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Campinas, Brazil
Last refreshed: 9 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05343078.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing