UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney Disease
Title of the study (Brief title)	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	Eiji Higashihara
Organization	Kyorin University School of Medicine
Division name	ADPKD Research
Address	6-20-2 Shinkawa, Mitaka, Tokyo
TEL	0422-49-7428
Email	ehigashi@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Eiji Higashihara
Organization	Kyorin University School of Medicine
Division name	ADPKD Research
Address	6-20-2 Shinkawa, Mitaka, Tokyo
TEL	0422-49-7428
Homepage URL
Email	ehigashi@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018272