The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial
Not Applicable
- Conditions
- Autosomal dominant polycystic kidney disease (ADPKD)
- Registration Number
- JPRN-UMIN000046275
- Lead Sponsor
- Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)