UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of phosphate binder on serum level of FGF23: A comparison between ferric citrate hydrate and lanthanum carbonate.
Title of the study (Brief title)	Effect of phosphate binder on FGF23.
Region	Japan

Condition
Condition	chronic kidney disease
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the influence of phosphate binder on FGF23 level
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of serum FGF23 levels after 1 and 3 months.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ferric citrate hydrate is orally administered for a month in the dose of 750 mg per day (every time after meal). It is allowed to raise its dose up to 1500 mg per day (every time after meal) for 2 months.
Interventions/Control_2	Lanthanum carbonate is orally administered for 3 months in the dose of 750 mg per day (every time after meal).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	CKD patients with hyperphosphatemia
Key exclusion criteria	Patients with iron excess
Target sample size	20

Research contact person
Name of lead principal investigator	Takeshi Nakanishi
Organization	Hyogo College of Medicine
Division name	Dep Internal Medicine, Div Kidney and Dialysis
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6521
Email	jin@hyo-med.ac.jp

Public contact
Name of contact person	Yukiko Hasuike
Organization	Hyogo College of Medicine
Division name	Dep Internal Medicine, Div Kidney and Dialysis
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6521
Homepage URL
Email	cherry39@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	self
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	兵庫医科大学（兵庫県），甲南病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 09 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 09 Month 24 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date	2016 Year 03 Month 31 Day
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	2015 Year 11 Month 06 Day
Last modified on	2016 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022606