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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-jRCTs031180369 |
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Date of registration:
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18/03/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tolvaptan for nephrogenic diabetes insipidus
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Scientific title:
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Exploratory study of tolvaptan use for nephrogenic diabetes insipidus caused by mutation in vasopressin type 2 receptor - Tolvaptan use for NDI by V2R mutation |
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Date of first enrolment:
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12/04/2018 |
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Target sample size:
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3 |
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Recruitment status: |
Recruiting |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs031180369 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), historical control, single assignment, treatment purpose
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Phase:
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1-2
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Contacts
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Name:
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Noriko
Makita |
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Address:
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7-3-1, Hongo, bunkyo-ku, Tokyo, Japan
113-8655
Tokyo
Japan |
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Telephone:
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+81-3-3815-5411 |
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Email:
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norimaki-tky@umin.ac.jp |
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Affiliation:
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The University of Tokyo Hospital |
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Name:
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Katsunori
Manaka |
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Address:
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7-3-1, Hongo, bunkyo-ku, Tokyo, Japan
113-8655
Tokyo
Japan |
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Telephone:
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+81-3-3815-5411 |
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Email:
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manaka-tky@umin.ac.jp |
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Affiliation:
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The University of Tokyo Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) > 20 y.o. or 20 y.o.
2) nephrogenic diabetes insipidus caused by mutations in AVPR2
3) Principal or sub investigators judge
4) Written informed consent
Exclusion criteria: 1) Allergic reactions against tolvaptan
2) Pregnant, unwilling to practice contraception during the study, or lactating female
3) < eGFR 30 mL/min/1.73m2
4) AST > 99 IU/L or ALT > 99 IU/L
5) congestive heart failure
6) active tuberculosis
7) alcohol abuse or drug abuse
8) participate in other studies with drug use within 4 months (if patch test, within 1 month)
9) blood sampling or donation 200 mL within 2 weeks, 400 mL within 12 weeks, or component blood sampling or donation within 12 weeks
10) Principal or sub investigators judge
Age minimum:
>= 20age old
Age maximum:
Not applicable
Gender:
Both
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Health Condition(s) or Problem(s) studied
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D018500
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Nephrogenic diabetes insipidus, polyuria
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Nephrogenic diabetes insipidus
Nephrogenic diabetes insipidus, polyuria
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Intervention(s)
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Starting tolvaptan from 60 mg and dose up to 90mg and 120mg in every 1 or 2 days.
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Tolvaptan
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Primary Outcome(s)
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Urine volume
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Secondary Outcome(s)
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1) Urine osmolarity, urine specific gravity, amount of drinking, aquaporin-2 in urine
2) safety
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Secondary ID(s)
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UMIN000021708
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Source(s) of Monetary Support
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Medical Corporation Keyaki-kai
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Ethics review
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Status: Approval
Approval date:
Contact:
ethics@m.u-tokyo.ac.jp
The University of Tokyo, Clinical Research Review Board
+81-3-5841-0818
ethics@m.u-tokyo.ac.jp
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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