Unique ID issued by UMIN | UMIN000046275 |
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Receipt number | R000052804 |
Scientific Title | The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial |
Date of disclosure of the study information | 2021/12/06 |
Last modified on | 2023/12/05 12:30:23 |
The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial
The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan
The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan: randomized crossover controlled trial
The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan
Japan |
Autosomal dominant polycystic kidney disease (ADPKD)
Nephrology |
Others
NO
To demonstrate the efficacy of dapagliflozin in ameliorating renal function decline and total kidney volume growth in ADPKD patients using tolvaptan
Efficacy
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]
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)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
2
Treatment
Medicine |
Dapagliflozin 10mg/day for 6 months
No treatment for 6 months
20 | years-old | <= |
Not applicable |
Male and Female
ADPKD patients using tolvaptan
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.
30
1st name | Kiyotaka |
Middle name | |
Last name | Uchiyama |
Keio University School of Medicine
Department of Endocrinology, Metabolism and Nephrology
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
+81-3-5363-3796
kiyo.0103.piyo@keio.jp
1st name | Kiyotaka |
Middle name | |
Last name | Uchiyama |
Keio University School of Medicine
Department of Endocrinology, Metabolism and Nephrology
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
+81-3-5363-3796
kiyo.0103.piyo@keio.jp
Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine
N/A
Other
Department of Nephrology, International University of Health and Welfare School of Medicine
Division of Nephrology, Japanese Red Cross Medical Center
Research Ethics Committee, Keio University, School of Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
+81-3-5363-3503
med-rinri-jimu@adst.keio.ac.jp
NO
慶應義塾大学病院(東京都)
国際医療福祉成田大学病院 (千葉県)
国際医療福祉大学病院(栃木県)
国際医療福祉大学熱海病院(静岡県)
日本赤十字社医療センター(東京都)
2021 | Year | 12 | Month | 06 | Day |
Unpublished
30
No longer recruiting
2021 | Year | 11 | Month | 30 | Day |
2021 | Year | 12 | Month | 03 | Day |
2021 | Year | 12 | Month | 11 | Day |
2023 | Year | 03 | Month | 31 | Day |
2021 | Year | 12 | Month | 03 | Day |
2023 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052804
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