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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-UMIN000021708 |
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Date of registration:
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18/04/2016 |
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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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A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene.
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Scientific title:
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A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene. - A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene. |
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Date of first enrolment:
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2016/04/18 |
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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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024903 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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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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Katsunori
Manaka |
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Address:
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7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
1138655
Japan |
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Telephone:
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03-3815-5411 |
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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 Nephrology and Endocrinology |
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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
Japan |
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Telephone:
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03-3815-5411 |
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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 Nephrology and Endocrinology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) History of allergy to tolvaptan 2) Pregnant women and women suspected of being pregnant 3) Severe Renaldysfunction (eGFR < 30 mL/min/1.73m2) 4) Severe liver dysfunction (AST > 100 U/L or ALT > 100 U/L) 5) Congestive heart failure 6) Active TBc 7) Substance use disorder 8) Use of investigational drug within 4 months before participation of this study 9) Amount of whole blood sampling > 200 mL within 4 weeks, amount of whole blood sampling > 400 mL within 12 weeks, or plasmapheresis / platelet apheresis within 2 weeks. 10) Doctor's decision
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene
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Intervention(s)
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1) Administration of Tolvaptan once per day (60mg/day, 90mg/day, 120mg/day), each dose for two days. 2) Administration of Tolvaptan 120mg per day for 2 to 4 weeks in outpatient.
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Primary Outcome(s)
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Urine Volume
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Secondary Outcome(s)
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Urine Osmolarity, amount of water drinking, Urine AQP2, safety
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Source(s) of Monetary Support
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Healthcare coopration
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Ethics review
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Status: YES
Approval date: 22/02/2016
Contact:
ethics@m.u-tokyo.ac.jp
The University of Tokyo, Clinical Research Review Board
03-5841-0818
ethics@m.u-tokyo.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/01/2024 |
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URL:
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