UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of phosphate binders in patients on hemodialysis
Title of the study (Brief title)	Phosphate binders in patients on HD
Region	Japan

Condition
Condition	Patients undergoing maintenance hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects and safety of phosphate binders
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in serum phosphate levels, hepcidin, and FGF23 levels
Key secondary outcomes	Changes in serum iron, TSAT, ferritin levels, hemoglobin concentration, dose of erythropoiesis stimulating agents, and erythropoietin responsiveness index, and safety.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Sucroferric oxyhydroxide or ferric citrate hydrate
Interventions/Control_2	Lanthanum carbonate
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) hemodialysis duration >2 years at enrollment, and (2) hyperphosphatemia that was treated with lanthanum carbonate at least 12 weeks before enrollment.
Key exclusion criteria	(1) a history of severe heart failure, angina, myocardial infarction, or stroke within the past 6 months; (2) the presence of infectious disease, malignant tumors, or treatment with steroids or immunosuppressants; (3) current hospitalization
Target sample size	60

Research contact person
Name of lead principal investigator	Masanori Abe
Organization	Nihon University School of Medicine
Division name	Nephrology, Hypertension and Endocrinology
Address	30-1, Oyaguchi Kami-cho, Itabsahi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	abe.masanori@nihon-u.ac.jp

Public contact
Name of contact person	Tomoyasu Otsuki
Organization	Nihon University School of Medicine
Division name	Nephrology, Hypertension and Endocrinology
Address	30-1, Oyaguchi Kami-cho, Itabsahi-ku, Tokyo, Japan
TEL	03-3972-8311
Homepage URL
Email	totsuki16@gmail.com

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Department of Nephrology, Hypertension and Endocrinology, Nihon University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	橋本みなみ内科本院（神奈川県）、優人クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 21 Day
Anticipated trial start date	2017 Year 01 Month 22 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	2018 Year 03 Month 14 Day
Last modified on	2018 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036232