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

JRCT ID: jRCT1051210190

Registered date:09/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: kidney transplantation
• Date of first enrollment: 18/03/2022
• Target sample size: 130
• Study type: Interventional

Intervention(s)

Dapagliflozin group: In addition to the standard treatment, dapagliflozin (10 mg orally once daily) will be started within 70 days of enrollment and continued until the end of treatment (104 weeks).
Non-treated group: Standard treatment will be continued.

Outcome(s)

• Primary Outcome: eGFR slope (mL/min/1.73 m2/year)

Secondary Outcome

(1) Change in eGFR
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)
(2) Changes in urine protein/creatinine ratio, urine beta2-MG/creatinine ratio, and urine beta2-MG concentration
(3) Changes in interstitial fibrosis and tubular atrophy in transplant kidney biopsy
(4) Effect on (renal) anemia: changes in TSAT, ferritin, hemoglobin, and erythropoietin
(5) Effect on bone mineral metabolism: changes in Ca, P, Mg, iPTH
(6) Rate of new-onset of malignancy
(7) Change in renal volume (calculated by CT)
(8) Change in the transplant kidney prognostic score (iBox)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Mizui Masayuki