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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015245 |
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Date of registration:
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25/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment.
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Scientific title:
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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. |
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Date of first enrolment:
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2014/09/25 |
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Target sample size:
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100 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017722 |
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Study type:
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Interventional |
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Study design:
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Factorial Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kosaku
Nitta |
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Address:
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8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
Japan |
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Telephone:
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0333538111 |
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Email:
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mtoshi@twmu.ac.jp |
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Affiliation:
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Tokyo Women's Medical University Department of Medicine four |
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Name:
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Toshio
Mochizuki |
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Address:
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Kawada-cho
162-8666
Japan |
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Telephone:
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0333538111 |
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Email:
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mtoshi@twmu.ac.jp |
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Affiliation:
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Tokyo Women's Medical University Department of Nephrology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (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.
Age minimum:
15years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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autosomal dominant polycystic kidney disease (ADPKD)
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Intervention(s)
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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)
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Primary Outcome(s)
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change of kidney function (eGFR)
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Secondary Outcome(s)
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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)
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 26/08/2014
Contact:
krinri.bm@twmu.ac.jp
Ethics committee, Tokyo Women's Medical University
0333538111
krinri.bm@twmu.ac.jp
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