UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Oral administration of sucroferric oxyhydroxide during hemodialysis sessions against resistant hyperphosphatemia
Title of the study (Brief title)	Sucroferric oxyhydroxide against hyperphosphatemia
Region	Japan

Condition
Condition	Resistant hyperphosphatemia in maintenance hemodialysis patients
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the effect of sucroferric oxyhydroxide during hemdialysis sessions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	reduction of serum phosphate levels
Key secondary outcomes	Serum FGF-23 levels, adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of chuwable tablets of sucroferric oxyhydroxide during hemodialysis sessions(1-6T in each session)
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Resistant hyperphosphatemia in hemodialysis patients
Key exclusion criteria	patients with risk od aspiration
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshitaka Maeda
Organization	JA Toride Medical Center
Division name	Dialysis center
Address	2-1-1 Hingo, Tiride, Ibaraki, Japan
TEL	81-297-74-5551
Email	yoshimaeda43@toride-medical.or.jp

Public contact
Name of contact person	Yoshitaka Maeda
Organization	JA Toride Medical Center
Division name	Dialysis Center
Address	2-1-1 Hingo, Tiride, Ibaraki, Japan
TEL	81-297-74-5551
Homepage URL
Email	yoshimaeda43@toride-medical.or.jp

Sponsor
Institute	Dialysis Center, JA Toride Medical Center
Institute
Department

Funding Source
Organization	JA Toride Medical Center
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	JA とりで総合医療センター

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 07 Day
Anticipated trial start date	2017 Year 04 Month 08 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 09 Month 30 Day
Date trial data considered complete	2020 Year 03 Month 30 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 16 Day
Last modified on	2018 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035775