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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033968
Receipt No. R000038741
Scientific Title Short term impact of tolvaptan withdrawal in patients with ADPKD.
Date of disclosure of the study information 2018/08/31
Last modified on 2019/04/09

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Basic information
Public title Short term impact of tolvaptan withdrawal in patients with ADPKD.
Acronym Short term impact of tolvaptan withdrawal in patients with ADPKD.
Scientific Title Short term impact of tolvaptan withdrawal in patients with ADPKD.
Scientific Title:Acronym Short term impact of tolvaptan withdrawal in patients with ADPKD.
Region
Japan

Condition
Condition Autosomal dominant polycystic kidney disease: ADPKD
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By examining the clinical laboratory test value and medical treatment contents of PKD patients who have used tolvaptan in the trial, we will examine the effectiveness of this drug and the effect on renal function due to discontinuation and use it for better PKD medical treatment in the future.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change in the slope of kidney function as mesured by the reciprocal of the GFR, total kidney volume.
Key secondary outcomes The slope of change in serum creatinine level, sodium level, gravity of urine.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Outpatients with PKD at our hospital who participated in the domestic test of tolvaptan.
Key exclusion criteria Patients who self-suspended hospitalization.
Patients who did not obtain consent.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Naoko / Mariko
Middle name
Last name Shimoda / Ikeda
Organization Nippon Medial School Hospital
Division name Department of Nephrology
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 Japan
TEL 0338222131
Email shimodana05@nms.ac.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Shimoda
Organization Nippon Medial School Hospital
Division name Department of Nephrology
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 Japan
TEL 0338222131
Homepage URL
Email shimodana05@nms.ac.jp

Sponsor
Institute Nippon Medial School Hospital
Institute
Department

Funding Source
Organization Nippon Medial School Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nippon Medial School Hospital
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603 Japan
Tel 0338222131
Email app-ccr@nms.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本医科大学附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 9
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 08 Month 31 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038741

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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