UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013366 |
|---|---|
| Receipt number | R000015393 |
| Scientific Title | Features of responders to Tolvaptan in CKD patients |
| Date of disclosure of the study information | 2014/03/07 |
| Last modified on | 2016/09/08 09:51:02 |
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Basic information
Public title
Features of responders to Tolvaptan in CKD patients
Acronym
CKD-FORT study
Scientific Title
Features of responders to Tolvaptan in CKD patients
Scientific Title:Acronym
CKD-FORT study
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the short-term and long-term impact of Tolvaptan in advanced stage CKD patients by observing the efficacy of the drug and other selected parameters.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Urine output after initiating Tolvaptan
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are as follows: CKD 4 and 5 patients with volume overload and insufficient response to loop or other diuretic agents; older than 20 years old; being able to express clear understanding of the purpose of the study; being able to complete a written informed consent.
Patients gender will not be restricted. Informed consent can be obtained by families for those who are not able to write it by themselves.
Key exclusion criteria
1. Previous history of tolvaptan use
2. Contraindication for tolvaptan
3. Unable to take an oral medication
4. Requiring immediate dialysis therapy
5. Pregnant or wish to be pregnant
7. History of major surgery within 60 days
8. History of acute myocardial infarction within 30 days
9. Severe hepatic failure or heart disease
10. Other cases which treating physicians regards as inappropriate for a candidate
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sei Sasaki |
Organization
Tokyo Medical and Dental University
Division name
Department of Nephrology
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo, Japan
TEL
03-5803-5214
tokado.kid@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomokazu Okado |
Organization
Tokyo Medical and Dental University
Division name
Department of Chronic Kidney Disease
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo, Japan
TEL
03-5803-5214
Homepage URL
http://www.tmd.ac.jp/grad/kid/kid-J.htm
tokado.kid@tmd.ac.jp
Sponsor or person
Institute
Department of Nephrology, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Affiliated hospitals of Tokyo Medical and Dental University Hospital
Name of secondary funder(s)
none
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
東京医科歯科大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 07 | Day |
Last modified on
| 2016 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015393
