The effect of dapagliflozin on allograft function following kidney transplantation: A randomized controlled open-label study (ALL-FOR-ONE study)

Phase 4

Recruiting

• Conditions: kidney transplantation

• Registration Number: JPRN-jRCT1051210190
• Lead Sponsor: Mizui Masayuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

All of the following criteria are met
(1) Patients aged 20 years or older but less than 80 years
(2) Patients with an eGFR of 30 mL/min/1.73 m2 or higher during the screening period (data within 3 months prior to enrollment are acceptable)
(3) Patients who have undergone kidney transplantation for more than 1 year
(4) Patients who have given written consent

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from this study.
(1) Patients with a history of organ transplantation other than kidney
(2) Patients on SGLT2 inhibitor (if the medication was terminated more than 6 months ago, it is acceptable)
(3) Patients who are not expected to survive for more than 2 years after enrollment
(4) Patients who have experienced rejection within 3 months
(5) Women who plan to become pregnant within 3 years
(6) Lactating women, pregnant women or patients who may be pregnant
(7) Patients suffering from active infectious disease
(8) Patients with a history of hypersensitivity to the components of dapagliflozin products.
(9) Patients who are judged inappropriate by the principal investigator or sub-investigator for other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eGFR slope (mL/min/1.73 m2/year)

Secondary Outcome Measures

Name	Time	Method
(1) Change in eGFR<br>Change in eGFR value at the end of observation (4 weeks after the end of treatment) relative to Baseline eGFR value (mL/min/1.73 m2)<br>(2) Changes in urine protein/creatinine ratio and urine beta2-MG/creatinine ratio<br>(3) Changes in interstitial fibrosis and tubular atrophy in transplant kidney biopsy<br>(4) Effect on (renal) anemia: changes in TSAT, ferritin, hemoglobin, and erythropoietin<br>(5) Effect on bone mineral metabolism: changes in Ca, P, Mg, iPTH<br>(6) Rate of new-onset of malignancy<br>(7) Change in renal volume (calculated by CT)<br>(8) Change in the transplant kidney prognostic score (iBox)