UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of lanthanum carbonate on arterial stiffness in patients with CKD 3-5 not on dialysis
Title of the study (Brief title)	Effects of lanthanum carbonate on arterial stiffness in patients with CKD 3-5 not on dialysis
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 markers of arterial stiffness, left ventricular mass and oxidative stress in chronic kidney disease (CKD) stage 3-5 not on dialysis.
Basic objectives2	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 follows : Pulse wave velocity, Left ventricular mass and oxidative stress makers (nitrotyrosine, AGE, RAGE, Urinary 8-OHdG, Skin accumulation of AGE)
Key secondary outcomes	Change from baseline and compare between 2 groups, as follows: Phosphate, Calcium, FGF-23, soluble alfa-Klotho , iPTH, eGFR, Cr,1/Cr, OC, CRP

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	1) Patients with CKD stage G3-G5 (eGFR< 60mL/min/1.73m2 ) not on dialysis 2) CKD-MBD patients without receiving phosphate binder treatment (%TRP<85% ) 3) Written informed consent
Key exclusion criteria	1) <20years old 2) Treatment with lanthanum carbonate within the past two months 3) Contraindications to lanthanum carbonate 4) Inflammatory disease 5) Malignancy of any type 6) History of renal transplantation 7) Pregnant or breast-feeding women 8) Ineligible patients for this study according to the investigator's judgment
Target sample size	120

Research contact person
Name of lead principal investigator	Kei Fukami
Organization	Kurume University School of Medicine
Division name	Division of Nephrology, Department of Medicine
Address	67 Asahi-machi, Kurume city, Fukuoka
TEL	+81-942-35-3311
Email	fukami@med.kurume-u.ac.jp

Public contact
Name of contact person	Kei Fukami
Organization	Kurume University School of Medicine
Division name	Division of Nephrology, Department of Medicine
Address	67 Asahi-machi, Kurume city, Fukuoka
TEL	+81-942-35-3311
Homepage URL
Email	fukami@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of Medicine
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	久留米大学病院（福岡県）/Kurume University School of Medicine (Fukuoka)

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 12 Day
Anticipated trial start date	2015 Year 03 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 23 Day
Last modified on	2018 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019270