UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in FGF23 and soluble Klotho levels in incident hemodialysis patients
Title of the study (Brief title)	Changes in FGF23 and soluble Klotho levels in incident hemodialysis patients
Region	Japan

Condition
Condition	End Stage Renal Disease
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine changes in FGF23 and soluble Klotho after initiation of hemodialysis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decrease in FGF 23 in short-term after initiation of hemodialysis
Key secondary outcomes	Decrease in soluble Koltho and intact PTH in short-term after initiation of hemodialysis

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	Incident dialysis patients with chronic renal failure
Key exclusion criteria	Switching from peritoneal dialysis and combination with peritoneal dialysis
Target sample size	50

Research contact person
Name of lead principal investigator	Masafumi Fukagawa
Organization	Tokai University School of Medicine
Division name	Division of Nephrology, Endocrinology and Metabolism
Address	143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL	0463-93-1121
Email	fukagawa@tokai-u.jp

Public contact
Name of contact person	Chiaki Kawabata
Organization	Tokai University School of Medicine
Division name	Division of Nephrology, Endocrinology and Metabolism
Address	143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL	0463-93-1121
Homepage URL
Email	superlatino818@gmail.com

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Under application
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	2016 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 25 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This prospective study examines changes in FGF23 and soluble Klotho in incident dialysis patients.

Management information
Registered date	2016 Year 08 Month 08 Day
Last modified on	2017 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026953