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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-UMIN000015715 |
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Date of registration:
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25/11/2014 |
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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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Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney Disease
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Scientific title:
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Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney Disease - Efficacy Study of Tolvaptan |
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Date of first enrolment:
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2014/11/20 |
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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=R000018272 |
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Study type:
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Interventional,observational |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase IV
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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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Eiji Higashihara |
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Address:
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6-20-2 Shinkawa, Mitaka, Tokyo
Japan |
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Telephone:
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0422-49-7428 |
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Email:
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ehigashi@ks.kyorin-u.ac.jp |
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Affiliation:
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Kyorin University School of Medicine ADPKD Research |
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Name:
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Eiji Higashihara |
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Address:
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6-20-2 Shinkawa, Mitaka, Tokyo
Japan |
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Telephone:
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0422-49-7428 |
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Email:
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ehigashi@ks.kyorin-u.ac.jp |
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Affiliation:
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Kyorin University School of Medicine ADPKD Research |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)Patients who did not or will not give consent to participate to the study protocol. 2)Patients who is considered to be excluded by physicians.
Age minimum:
18years-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
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Intervention(s)
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Tolvaptan administration
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Primary Outcome(s)
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Annual change rate of Total Kidney Volume (TKV slope; ml/year, % /year)
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Secondary Outcome(s)
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Annual change rate of eGFR (eGFR slope; ml/min/1.73m2 per year) which is estimated by creatinine and cystatin-C.
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Source(s) of Monetary Support
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Kyorin University School of Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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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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