Diabetic patients who have undergone kidney-related surgery Diabetic patients who have undergone kidney-related surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients who have undergone kidney surgery (2) Patients with diabetes mellitus who have an HbA1c >= 6.5% or are being treated with antidiabetic medication within 1 year prior to obtaining consent. (3) Patients with Chronic Kidney Disease (CKD). (4) Age: 18 years or older and less than 85 years at the time of obtaining consent. (5) Sex: Any. (6) Patients who have given written informed consent of their own free will after receiving a full explanation regarding participation in this study and fully understanding the contents. (7) Patients who are able to visit the outpatient clinic according to the study schedule
Exclusion criteria
Exclusion criteria: (1) Patients requiring treatment with anticancer drugs or similar agents. (2) Patients with active renal or systemic inflammation. (3) Patients with an eGFR 4.8 mEq/L at the time of enrollment. (7) Patients with severe hepatic impairment (Child-Pugh Class C). (8) Patients with Addison's disease. (9) Patients who are pregnant or possibly pregnant. (10) Patients who are breastfeeding. (11) Any other patients deemed ineligible for participation in this study by the Principal Investigator or Co-Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events for which a causal relationship with the investigational drug cannot be ruled out | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Degree of improvement in renal function at 24 weeks after administration. (2) Degree of improvement in proteinuria at 24 weeks after administration. (3) Renal ultrasonography assessment at 24 weeks after administration. (4) Incidence of all adverse events | — |
Contacts
The University of Tokyo Hospital