DARS study

JRCT ID: jRCT1031220661

Registered date:27/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: renal dysfunction
• Date of first enrollment: 27/02/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Incidence of adverse events

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamada Daisuke