UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of ferric citrate hydrate in chronic kidney disease with mild hyperphosphatemia: randomized controlled open-labeled trial
Acronym	FC CKD study
Scientific Title	The efficacy of ferric citrate hydrate in chronic kidney disease with mild hyperphosphatemia: randomized controlled open-labeled trial
Scientific Title:Acronym	FC CKD study
Region	Japan

Condition
Condition	predialysis chronic kidney disease (predialysis CKD)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of ferric citrate hydrate in chronic kidney disease patients with mild hyperphosphatemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	global outcome as both kidney outcome and CVD events.
Key secondary outcomes	renal dysfunction rate, onset of CVD, bone fracture, the frequency of infection, effects of anemia, effects of CKD-MBD, effects of medication

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Behavior,custom
Interventions/Control_1	CKD patients with mild hyperphosphatemia(P4-6mg/dl) having been under a diet treatment, administered orally ferric citrate hydrate for phosphate normalization.
Interventions/Control_2	CKD patients with mild hyperphosphatemia(P4-6mg/dl) having been under a diet treatment, keep protein diet therapy.
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	CKD patients with mild hyperphosphatemia(P4-6mg/dl) having been under a diet treatment
Key exclusion criteria	1)impossible dose of ferric citrate hydrate 2)already medicated by other phsphate binders 3)patients participating in other clinical intervention trial 4)presence of severe complication 5)Physician's decision
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Nobukazu Ishizaka
Organization	osaka medical college
Division name	Internal medicine 3
Zip code
Address	2-7, Daigakumachi, Takatsuki-shi, Osaka, Japan
TEL	072-683-1221
Email	ishizaka@osaka-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hideaki Shima
Organization	Osaka Medical College
Division name	Nephrology
Zip code
Address	2-7, daigaku-machi, Takatsuki-shi, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	in3130@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College, department of Internal Medicine 3
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 05 Month 15 Day
Date of IRB	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2018 Year 08 Month 15 Day
Date of closure to data entry	2018 Year 08 Month 15 Day
Date trial data considered complete	2018 Year 08 Month 15 Day
Date analysis concluded	2018 Year 08 Month 15 Day

Other
Other related information	Termination of clinical trial due to trouble

Management information
Registered date	2015 Year 06 Month 29 Day
Last modified on	2019 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020396