UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Features of responders to Tolvaptan in CKD patients
Title of the study (Brief title)	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	Sei Sasaki
Organization	Tokyo Medical and Dental University
Division name	Department of Nephrology
Address	1-5-45 Yushima Bunkyo-ku Tokyo, Japan
TEL	03-5803-5214
Email	tokado.kid@tmd.ac.jp

Public contact
Name of contact person	Tomokazu Okado
Organization	Tokyo Medical and Dental University
Division name	Department of Chronic Kidney Disease
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
Email	tokado.kid@tmd.ac.jp

Sponsor
Institute	Department of Nephrology, Tokyo Medical and Dental University
Institute
Department

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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015393