UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial of lanthanum carbonate versus calcium carbonate on coronary artery calcification in patients new to dialysis
Title of the study (Brief title)	Effect of lanthanum carbonate on coronary artery calcification in patients new to dialysis
Region	Japan

Condition
Condition	End-stage renal disease (at the induction of dialysis)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of lanthanum carbonate on coronary artery calcification in patients new to dialysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes of coronary artery calcification score (Agatston score)
Key secondary outcomes	echocardiography, heart valve calcification, aortic calcification, vascular stiffness, carotid IMT, bone density, bone metabolic markers, ADMA, oxidative stress, high-sensitive CRP

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	lanthanum carbonate
Interventions/Control_2	calcium carbonate
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	Patients new to hemodialysis with hyperphosphatemia
Key exclusion criteria	1)Patients who have contraindication to lanthanum carbonate or calcium carbonate 2)Patients with history of parathyroidectomy 3)Gastrointestinal disorder 4)Patients with history of illeus 5)CAPD(continuous ambulatory peritoneal dialysis) 6)Pregnant and breast-feeding 7)Patients judged as being inappropriate for this study by investigators
Target sample size	100

Research contact person
Name of lead principal investigator	Shinichi Nishi
Organization	Kobe university graduate school of medicine
Division name	Division of nephrology and kidney Center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
TEL	(078)382-6500
Email	snishi@med.kobe-u.ac.jp

Public contact
Name of contact person	Hideki Fujii
Organization	Kobe university graduate school of medicine
Division name	Division of nephrology and kidney center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
TEL	(078)382-6500
Homepage URL
Email	fhideki@med.kobe-u.ac.jp

Sponsor
Institute	Division of nephrology & kidney center, Kobe university graduate school of medicine.
Institute
Department

Funding Source
Organization	Division of nephrology and kidney center, Kobe university graduate school of medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Bayer,The kidney foundation Japan

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	千船病院、甲南病院、六甲アイランド病院、明石医療センター、西脇市立病院、高砂市民病院、城陽江尻病院

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 01 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2016 Year 02 Month 28 Day
Date of closure to data entry	2016 Year 04 Month 01 Day
Date trial data considered complete	2016 Year 04 Month 01 Day
Date analysis concluded	2016 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007%2Fs00223-017-0347-3
Results
Other related information

Management information
Registered date	2011 Year 11 Month 30 Day
Last modified on	2017 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007749