UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective Study examining The contribution to Renal anemia treatment of ferric citrate hydrate, an Ironbased Oral phosphate binder, in hemodialysis patients with hyperphosphatemia : ASTRIO Study
Title of the study (Brief title)	ASTRIO Study
Region	Japan

Condition
Condition	Maintenance hemodialysis patients with hyperphosphatemia
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of ferric citrate hydrate administrated for hyperphosphatemia on renal anemia treatment in maintenance hemodialysis patents undergoing ESA therapy by comparing with non-iron based phosphate binders.
Basic objectives2	Others
Basic objectives -Others	Secondary effect on treatment of renal anemia
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in ESA dose from baseline to the end of treatment.
Key secondary outcomes	1) Cumulative dose of intravenous iron during the study. 2) Cumulative dose of ESA during the study. 3) ESA dose at each observation. 4) ERI at each observation. 5) Red blood cell related parameters at each observation. 6) Iron related parameters at each observation. 7) CKD-MBD related parameters at each observation.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients will be treated for 24 weeks with ferric citrate hydrate switched from phosphate binder that has been used before entry.
Interventions/Control_2	Patients will be treated for 24weeks with previous phosphate binder used before entry.
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 receiving hemodialysis 2) Patients receiving non-iron based phosphate binders. 3) Patients receiving a constant dose of ESA 4) Patients who provided voluntary informed consent to participate in the study
Key exclusion criteria	1) Patients who have administrated of oral iron agents within 4weeks before entry. 2) Patients with uncontrolled serum P 3) Patients with uncontrolled serum Ca 4) Patients with uncontrolled serum Hb 5) Patients with uncontrolled hypertension
Target sample size	90

Research contact person
Name of lead principal investigator	Keitaro Yokoyama
Organization	The Jikei University School of Medicine
Division name	Division of Nephrology and Hypertension, Department of Internal Medicine
Address	3-25-8, Nishi-Shinbashi,Minato-ku,Tokyo
TEL	03-3433-1111
Email	keitaro@jikei.ac.jp

Public contact
Name of contact person	Kotaro Senuki
Organization	Sogo Rinsho Medefi Co., Ltd
Division name	Project promotion department
Address	KDX Shinjuku Bldg. 9F 3-2-7 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-6901-6079
Homepage URL
Email	RIO-J01@sogo-medefi.jp

Sponsor
Institute	Japan Tobacco Inc.
Institute
Department

Funding Source
Organization	Japan Tobacco Inc. Torii Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	2015 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 13 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2016 Year 08 Month 08 Day
Date of closure to data entry	2016 Year 10 Month 31 Day
Date trial data considered complete	2016 Year 11 Month 30 Day
Date analysis concluded	2017 Year 01 Month 26 Day

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

Management information
Registered date	2015 Year 09 Month 30 Day
Last modified on	2017 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022171