UMIN-CTR Clinical Trial

Basic information
Public title	Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
Acronym	Lanthanum Versus Calcium Carbonate for Patients With CKD
Scientific Title	Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
Scientific Title:Acronym	Lanthanum Versus Calcium Carbonate for Patients With CKD
Region	Japan

Condition
Condition	pre-dialysis CKD
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Coronary artery calcification score [ Time Frame: 1 year ]
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Active Comparator: Calcium carbonate Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 3,000 mg/day.
Interventions/Control_2	Experimental: Lanthanum carbonate Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 1,500 mg/day.
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) 20 Years and older (2) Hyperphosphatemia (For patients without calcium carbonate, 4.5- mg/dL) (For Patients with calcium carbonate, 4.0- mg/dL) (3) With written informed consent
Key exclusion criteria	(1) History of cardiac surgery and/or coronary artery stenting (2) Polycystic kidney disease (3) Hypothyroidism (4) On treatment with lanthanum carbonate (5) History of admission within 3 months (6) History of ileus (7) Severe gastrointestinal dysfunction (8) Severe liver dysfunction (9) Allergy to lanthanum carbonate or calcium carbonate (10) Pregnant or breastfeeding women (11) Judged as ineligible by primary physicians
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Sakaguchi Middle name Last name Yusuke
Organization	Osaka University Hospital
Division name	Department of Nephrology
Zip code	565-0871
Address	2-15, Yamada-oka, Suita, Osaka
TEL	06-6879-3857
Email	sakaguchi@kid.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Sakaguchi Middle name Last name Yusuke
Organization	Osaka University Hospital
Division name	Department of Nephrology
Zip code	565-0871
Address	2-15, Yamada-oka, Suita, Osaka
TEL	06-6879-3857
Homepage URL
Email	sakaguchi@kid.med.osaka-u.ac.jp

Sponsor
Institute	Department of Nephrology, Osaka University Hospital
Institute
Department

Funding Source
Organization	This study is funded by Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University
Address	2-15, Yamada-oka, Suita, Osaka
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT02237534
Org. issuing International ID_1	ClinicalTrials.gov Identifier
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 13 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	Completed
Date of protocol fixation	2014 Year 06 Month 02 Day
Date of IRB	2014 Year 06 Month 02 Day
Anticipated trial start date	2014 Year 06 Month 02 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 12 Day
Last modified on	2022 Year 03 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040476