UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the efficacy of sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MBD and improvement of renal anemia in hemodialysis patients with hyperphosphatemia.
Title of the study (Brief title)	Study of the efficacy of sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MBD and improvement of renal anemia in hemodialysis patients with hyperphosphatemia.
Region	Japan

Condition
Condition	Hyperphosphatemia in chronic kidney disease patients on hemodialysis
Classification by specialty	Endocrinology and Metabolism Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of switching existing drugs for the treatment of hyperphosphatemia to sucroferric oxyhydroxide (chewable tablet) on the control of CKD-MDB and the improvement of renal anemia in hemodialysis patients with hyperphosphatemia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Efficacy endpoints: 1)Serum phosphate concentration (change in serum phosphate concentration, rate and timing of achievement of target serum phosphate concentration) at each evaluation point 2)Laboratory test data related to red blood cells at each evaluation point 3)Corrected serum calcium concentration at each evaluation point 4)Serum intact-PTH concentration at each evaluation point 5)Ca-P product at each evaluation point 6)FGF23 level at each evaluation point 7)Dose of calcium carbonate at each evaluation point 8)Dose of the study drug at each evaluation point 9)Cumulative dose of ESA during the study drug administration period 10)Cumulative dose of intravenous iron during the study drug administration period Safety endpoints: 1)Adverse events 2)Adverse drug reactions 3)Laboratory test data related to iron at each evaluation point 4)Highly sensitive CRP level at each evaluation point
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switch existing drugs for the treatment of hyperphosphatemia to the administration of sucroferric oxyhydroxide TID for 16 weeks.
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	1)Patients who have been undergoing hemodialysis (HD or HDF) 3 or more times/week for 12 weeks or longer prior to entry and are scheduled to receive hemodialysis under the same procedures and conditions 2)Patients who have been treated with drugs for hyperphosphatemia other than the study drug at a dose exceeding a specific level for 4 weeks or longer prior to entry 3)Patients with a serum phosphate level of more than 6 mg/dL at the latest examination prior to entry 4)Patients aged 20 years or older at the time of consent 5)Patients who have given written consent
Key exclusion criteria	1)Patients with a serum ferritin level of 300 ng/mL or more at the latest examination prior to entry 2)Patients with a history of hypersensitivity to the ingredients of sucroferric oxyhydroxide (chewable tablet) 3)Patients who are or may be pregnant or are breast-feeding 4)Patients who are considered inappropriate for participation in this study by the investigator's judgment
Target sample size	50

Research contact person
Name of lead principal investigator	Keiko Miya
Organization	Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name	Department of Internal Medicine and Dialysis Internal Medicine
Address	1-39 Kitasakoichibancho, Tokushima-shi, Tokushima
TEL	088-631-0110
Email	miya@khg.or.jp

Public contact
Name of contact person	Akiko Miyajima
Organization	Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name	General Affairs Section
Address	1-39 Kitasakoichibancho, Tokushima-shi, Tokushima
TEL	088-631-0110
Homepage URL
Email	a.miyajima@khg.or.jp

Sponsor
Institute	Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Institute
Department

Funding Source
Organization	Kissei Pharmaceutical Co.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kawashima Dialysis Clinic, Social Medical Corporation Kawashima Hospital Group Kamoshima Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group Naruto Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group Wakimachi Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group Anan Kawashima Clinic, Social Medical Corporation Kawashima Hospital Group
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	社会医療法人川島会　川島病院（徳島県） 社会医療法人川島会　川島透析クリニック（徳島県） 社会医療法人川島会　鴨島川島クリニック（徳島県） 社会医療法人川島会　鳴門川島クリニック（徳島県） 社会医療法人川島会　脇町川島クリニック（徳島県） 社会医療法人川島会　阿南川島クリニック（徳島県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 21 Day
Anticipated trial start date	2016 Year 09 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 17 Day
Last modified on	2018 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027243