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DARS study

Exploratory study on the safety of oral administration of dapagliflozin for renal dysfunction in patients with renal surgery - DARS study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031220661
Enrollment
10
Registered
2023-02-27
Start date
2024-05-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal dysfunction Chronic renal failure

Interventions

Dapagliflozin propylene glycol hydrate is administered at a dose of 10 mg once daily for 6 months from the start of treatment until the end of treatment.

Sponsors

Yamada Daisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with renal surgery (regardless of time since renal surgery) 2. Patients with an eGFR of 25-59mL/min/1.73m2 for more than 3 months 3. Age: Those who are between 18 and 85 years of age at the time of obtaining consent 4. Male or female 5. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study 6. Those who can make outpatient visits in accordance with the research implementation schedule

Exclusion criteria

Exclusion criteria: 1. Patients who need treatment such as anticancer drugs 2. Patients with active renal or systemic inflammation 3. Those who are allergic to dapagliflozin 4. Those who are pregnant or may become pregnant 5. Those who are breastfeeding 6. Those who are judged inappropriate for participation in this study by the principal investigator or co-investigator

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events

Secondary

MeasureTime frame
1. Degree of renal function improvement (serum creatinine, eGFR, cystatin C) 2. Degree of urinary protein improvement (urinary protein, albumin, creatinine) 3. Ultrasound examination (renal size, thickness of renal parenchyma, presence or absence of hydronephrosis, presence or absence of abnormality)

Contacts

Public ContactDaisuke Yamada

The University of Tokyo Hospital

dyamada-tky@umin.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026