NIPH Clinical Trials Search

JRCT ID: jRCT1051210190

Registered date:09/03/2022

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedkidney transplantation
Date of first enrollment18/03/2022
Target sample size130
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeeGFR 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 and urine beta2-MG/creatinine ratio (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
Include criteriaAll 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 criteriaPatients 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


Public contact
Name Yohei Doi
Address 2-15 Yamada-oka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3857
Affiliation Osaka University Hospital
Scientific contact
Name Masayuki Mizui
Address 2-15 Yamada-oka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3857
Affiliation Osaka University Hospital