UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033968 |
|---|---|
| Receipt number | 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 15:44:27 |
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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
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
shimodana05@nms.ac.jp
Sponsor or person
Institute
Nippon Medial School Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038741
