UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of lanthanum carbonate on hyperphosphatemia in chronic kidney disease patients not on dialysis.
Title of the study (Brief title)	ELAC-Hyper-CKD (Effect of LAnthanum Carbonate on Hyperphosphatemia in Chronic Kidney Disease patients)
Region	Japan

Condition
Condition	non-dialysis chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of lanthanum carbonate and/or existing treatment on FGF23 level in chronic kidney disease (CKD) patients not on dialysis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Change from baseline and compare between 2 groups, as follow items : FGF23, alfa-Klotho and sclerostin (at 2 months)
Key secondary outcomes	Change from baseline and compare between 2 groups, as follows: Phosphate, Calcium, Phosphate excretion in urine, iPTH, wPTH (at 2 months) delta-FGF23, eGFR, 1/Cr, Cr, iPTH, wPTH, BAP, TRACP-5b, OPG, Mg (at 12 months)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Lanthanum carbonate
Interventions/Control_2	Existing treatment for chronic kidney disease
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	The patients of filling the following all criteria and having ability for agreement 1) Chronic kidney disease stage G3-G4 (15 mL/min/1.73m2<=GFR<60 mL/min/1.73m2) 2) Hyperphosphatemia patients without receiving phosphate binder treatment (serum phosphate>4.5 mg/dL) 3) Available for follow-up for at least 1 year in the opinion of the investigator
Key exclusion criteria	1)<20years old 2)Malignancy of any type 3)Contraindications to lanthanum carbonate 4)Diabetes mellitus 5)Renal transplant 6)Pregnant or breast-feeding women 7)Ineligible patients for this study according to the investigator's judgment
Target sample size	140

Research contact person
Name of lead principal investigator	Takashi Shigematsu
Organization	Wakayama Medical University
Division name	Division of Nephrology
Address	811-1, Kimiidera Wakayama city, Wakayama
TEL	+81-73-441-0638
Email	taki@wakatyama-med.ac.jp

Public contact
Name of contact person	Masaki Ohya
Organization	Wakayama Medical University
Division name	Division of Nephrology
Address	811-1, Kimiidera Wakayama city, Wakayama
TEL	+81-441-0639
Homepage URL
Email	m-ohya@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Bayer Yakuhin, 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	和歌山県立医科大学(和歌山県)

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 04 Month 15 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 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	2014 Year 09 Month 22 Day
Last modified on	2016 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017697