Autosomal dominant polycystic kidney disease (ADPKD)
Conditions
Interventions
Dapagliflozin 10mg/day for 6 months
No treatment for 6 months
Sponsors
Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine
Department of Nephrology, International University of Health and Welfare School of Medicine Division of Nephrology, Japanese Red Cross Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ADPKD patients using tolvaptan
Exclusion criteria
Exclusion criteria: Exclusion criteria are as follows: patients with eGFR less than 25 mL/min/1.73m2; diabetes mellitus (patients who are taking antidiabetic medication or meet the diagnostic criteria for diabetes mellitus); contraindications to the use of dapagliflozin (specifically, the following: patients with a history of hypersensitivity to any of the components of this drug; severe ketosis; diabetic coma, or precoma; severe infections, before and after surgery, or with severe trauma); less than 3 month-use of tolvaptan; deemed unsuitable as subjects by the study investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decline in renal function [eGFR slope is calculated using the least squares method for secular change in eGFR (mL/min/1.73m2/year) from one month to 6 months in each trial] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total kidney volume from baseline to 6 months in each trial Body weight, blood pressure, metabolic parameters (serum TC/HDL/TG, fasting glucose, HbA1c, HOMA-IR), CKD-related outcomes by urine storage (urine volume, urine osmolality, urine protein and trace albumin, L-FABP), etc., obtained at 6 months in each trial (or those changes from baseline to 6 months) | — |
Countries
Japan
Contacts
Public ContactKiyotaka Uchiyama
Keio University School of Medicine Department of Endocrinology, Metabolism and Nephrology
Outcome results
None listed