Unique ID issued by UMIN | UMIN000015245 |
---|---|
Receipt number | R000017722 |
Scientific Title | Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment. |
Date of disclosure of the study information | 2014/09/25 |
Last modified on | 2021/09/30 10:17:36 |
Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment.
ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment.
Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment.
ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment.
Japan |
autosomal dominant polycystic kidney disease (ADPKD)
Nephrology |
Others
NO
We investigate the efficacy and safety of tolvaptan as a new therapeutic drug for progressive autosomal dominant polycystic kidney disease(ADPKD).
Others
We investigate the determinants of disease progression and response to tolvaptan treatment in progressive autosomal dominant polycystic kidney disease (ADPKD) .
Confirmatory
Others
Not applicable
change of kidney function (eGFR)
total kidney volume
urine concentration
plasma AVP concentration
urine cAMP
incidence and severity of symptom related with ADPKD
(urine concentration ability, hypertension, kidney pain, kidney function, hematuria, kidney stone, kidney infection)
Interventional
Factorial
Non-randomized
Open -no one is blinded
Dose comparison
5
Treatment
Medicine |
tolvaptan 60~120mg/day
tolvaptan less than 60mg/day
(in case of minimize dose recommended, for example; kidney dysfunction)
tolvaptan less than 60mg/day
(in case of minimize dose recommended, for example; kidney dysfunction)
no medication
tolvaptan less than 60mg/day of start dose
(in case of minimize start dose recommended, for example; less than 20 years old or more than 65 years old)
15 | years-old | <= |
Not applicable |
Male and Female
1. ADPKD patient
2. total kidney volume is more than 750ml by CT or MRI, and also increased speed of total kidney volume is more than almost 5% per year.
3. The patient who was agreed informed consent.
(1) contraindicated patient of tolvaptan
1. patient who has past history of hypersensitivity to tolvaptan or similar compound (mozavaptan)
2. patient who is not able to feel thirst or is difficult to water intake.
3. hypernatremia
4. severe kidney dysfunction (eGFR less than 15mL/min/1.73m2)
5. present or past history of liver dysfunction by chronic hepatitis, or drug-induced liver dysfunction, excluding liver cyst in ADPKD
6. The pregnancy or the woman who may be pregnant.
(2) The patient judged inappropriate by study responsibility doctor.
100
1st name | Kosaku |
Middle name | |
Last name | Nitta |
Tokyo Women's Medical University
Department of Medicine four
162-8666
8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
0333538111
mtoshi@twmu.ac.jp
1st name | Toshio |
Middle name | |
Last name | Mochizuki |
Tokyo Women's Medical University
Department of Nephrology
162-8666
Kawada-cho
0333538111
mtoshi@twmu.ac.jp
Department of Nephrology, Tokyo Women's Medical University
None
Self funding
Ethics committee, Tokyo Women's Medical University
8-1 kawada-cho, Shinjuku-ku, Tokyo
0333538111
krinri.bm@twmu.ac.jp
NO
東京女子医科大学(東京都)
2014 | Year | 09 | Month | 25 | Day |
https://www.kireports.org/action/showPdf?pii=S2468-0249%2821%2901293-6
Published
https://www.kireports.org/action/showPdf?pii=S2468-0249%2821%2901293-6
92
The observation period was 2.4 years. U-AQP2 per milligram of urinary creatinine (U-AQP2/Cr) decreased from 67.8 to 20.7 fmol/mg urinary creatinine after 1 month of tolvaptan treatment. This initial change in U-AQP2/Cr was correlated with high baseline U-AQP2/Cr, low baseline eGFR, and a large initial change in eGFR (baseline to 1 month). The initial change in U-AQP2/Cr (baseline to 1 month) was strongly correlated with the annual change in TKV and eGFR in multivariable analysis.
2021 | Year | 09 | Month | 30 | Day |
Patients with ADPKD who were administered tolvaptan in our hospital.
Follow up of patients with ADPKD who were administered tolvaptan in our hospital.
Liver dysfunction
the annual change in total kidney volume
(TKV) and estimated glomerular filtration rate (eGFR)
Completed
2014 | Year | 09 | Month | 10 | Day |
2014 | Year | 08 | Month | 26 | Day |
2014 | Year | 09 | Month | 25 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2014 | Year | 09 | Month | 25 | Day |
2021 | Year | 09 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017722
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |