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

DARS study (DARS study)

10

2 cases of nephrectomy, 8 cases of partial nephrectomy

End of participation End of follow-up observation

Hypoglycemic attacks occurred in 1 of 10 patients (10%) from the first to second week of administration, but disappeared after the third week.

Efficacy evaluation (primary endpoint) Adverse event incidence: Hypoglycemic attacks occurred in 1 of 10 patients (10%). These occurred from the first to second week of administration, and disappeared after the third week. The exact confidence interval using the Clopper-Pearson method was 0.00252 0.445. Efficacy evaluation (secondary endpoint) (1) Degree of improvement in renal function (serum creatinine, eGFR, cystatin C) Serum creatinine: The mean difference (95% confidence interval) from the first week to the sixth week of administration was +0.049 (-0.05 to 0.14) to +0.022 (-0.02 to 0.07) eGFR: The mean difference (95% confidence interval) from the first week to the sixth week of administration was -1.60 (-4.54 to 1.34) to -1.22 (-3.77 to 1.33) Cystatin C: The mean difference (95% confidence interval) from 3 to 6 weeks of administration was +0.028 (-0.004 to 0.06) to -0.105 (-0.33 to 0.12) (2) Degree of improvement in urinary protein (urinary protein, albumin, creatinine) Urinary protein: The mean difference (95% confidence interval) from 1 to 6 weeks of administration was -2.22 (-22 to 17) -7.77 (-23 to 7.4) Urinary albumin: The mean difference (95% confidence interval) from 1st to 6th week of administration was +1.23 (-5.59 to 8.05) to -0.42 (-3.45 to 2.61) Urinary creatinine: The mean difference (95% confidence interval) from 1st to 6th week of administration was -16.9 (-44.7 to 12.3) to -19.9 (-51.3 to 11.5) (3) Ultrasound examination (renal size of kidney, thickness of renal parenchyma, presence or absence of hydronephrosis, presence or absence of abnormality) Kidney size: The average difference over 6 weeks of administration (95% confidence interval) Width 1.7 (-0.6~4.0) Thickness -0.3 (-5.0~4.4) Length 0.9 (-1.3~3.1) Renal parenchymal thickness: The average difference over 6 weeks of administration (95% confidence interval) is 0.7 (-1.2~2.6) Presence or absence of hydronephrosis: No change Presence or absence of abnormality: No change

Hypoglycemic attacks, a known adverse event, were observed in 10% of patients, but were resolved by ingesting sugar and disappeared after the third week. Dapagliflozin is considered to be safe to administer to patients with renal dysfunction after renal surgery.

Mar. 14, 2025

No

to be decided

https://jrct.mhlw.go.jp/latest-detail/jRCT1031220661

Yamada Daisuke

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

dyamada-tky@umin.ac.jp

Yamada Daisuke

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

+81-3-3815-5411

dyamada-tky@umin.ac.jp

Complete

Feb. 27, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

renal dysfunction

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.

Chronic renal failure

D007676

Incidence of adverse events

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)

+81-3-5841-0818

Feb. 01, 2023

none