UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015715 |
|---|---|
| Receipt number | R000018272 |
| Scientific Title | Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney Disease |
| Date of disclosure of the study information | 2014/11/25 |
| Last modified on | 2016/11/02 18:34:30 |
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Basic information
Public title
Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney Disease
Acronym
Efficacy Study of Tolvaptan
Scientific Title
Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney Disease
Scientific Title:Acronym
Efficacy Study of Tolvaptan
Region
| Japan |
Condition
Condition
Autosomal Dominant Polycystic Kidney Disease
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long-term study to evaluate efficacy of tolvaptan on ADPKD patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Annual change rate of Total Kidney Volume (TKV slope; ml/year, % /year)
Key secondary outcomes
Annual change rate of eGFR (eGFR slope; ml/min/1.73m2 per year) which is estimated by creatinine and cystatin-C.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tolvaptan administration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who started or will start tolvaptan treatment in our institute and gave or will give consent to participate to this study.
2)Patients who visited or will visit our institute, received or will receive clinical evaluations and gave or will give informed consent to use their clinical data.
Key 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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Higashihara |
Organization
Kyorin University School of Medicine
Division name
ADPKD Research
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-49-7428
ehigashi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Higashihara |
Organization
Kyorin University School of Medicine
Division name
ADPKD Research
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-49-7428
Homepage URL
ehigashi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 25 | 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
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 18 | Day |
Last modified on
| 2016 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018272
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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