UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective multicenter randomized trial on the effects of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification: Landmark Subsidiary Study
Title of the study (Brief title)	Randomized trial on the effects of Lanthanum Carbonate on coronary artery calcification: Landmark-SS
Region	Japan

Condition
Condition	Hemodialysis patients with hyperphosphatemia
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of coronary artery calcification between lanthanum carbonate and calcium carbonate in hemodialysis patients with hyperphosphatemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Change in coronary artery calcification score (Agatston Score) by MDCT for 2 years
Key secondary outcomes	-Percent change from baseline in Agatston Score - Change in serum phosphate - Change in serum adjusted calcium - Change oin intact-PTH

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Lanthanum carbonate treatment (Follow-up: 2 years)
Interventions/Control_2	Calcium carbonate treatment (Follow-up: 2 years)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	- hemodialysis patients with hyperphosphatemia who require phosphate binders - hemodialysis for more than 3 months - patients who have at lease one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus) - intact-PTH > or =240 pg/mL - life expectancy > 1 year - with written informed consent
Key exclusion criteria	- contraindications to Ca carbonate and La carbonate - swallowing disorders - severe GI disorders - history of obstructed bowels - history of IHD/stroke within 6 months - NYHA classification III-IV - severe liver dysfunction, AST or ALT greater than 3 times the upper limit of institution - require treatment of arrthythmia - severe malnutrition - malignancy of any type within the last 5 years - peritoneal dialysis patients - pregnant or possibly pregnant women or women on lactation and plan to get pregnant within study term - ineligible patients according to the investigator's judgment
Target sample size	400

Research contact person
Name of lead principal investigator	Tadao Akizawa
Organization	Showa University
Division name	Division of Nephrology, Department of Medicine
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	+81-3-3784-8000
Email	akizawa@med.showa-u.ac.jp

Public contact
Name of contact person	Hiroaki Ogata
Organization	Showa University Northern Yokohama Hospital
Division name	Department of Internal Medicine
Address	35-1 Chigasakichuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL	+81-45-949-7000
Homepage URL
Email	ogatah@med.showa-u.ac.jp

Sponsor
Institute	Landmark Study Group
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	Foundation for Biomedical Research and Innovation at Kobe
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT05178200
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 10 Month 17 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry	2017 Year 06 Month 02 Day
Date trial data considered complete	2017 Year 07 Month 04 Day
Date analysis concluded	2017 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 12 Month 01 Day
Last modified on	2018 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008049