UMIN-CTR Clinical Trial

Basic information
Public title	Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Acronym	Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Scientific Title	Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Scientific Title:Acronym	Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate on vascular calcification in hemodialysis patients
Region	Japan

Condition
Condition	end-stage renal disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the difference of vascular calcification between lanthanum carbonate and calcium carbonate administered group in hemodialysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Abdominal aortic calcification (Progression of abdominal aortic calcification volume detected by computed tomography image for renal carcinoma screening)
Key secondary outcomes	1) Phosphorus and calcium level achievement rate as defined by the Japanese Society for Dialysis Therapy guideline 2) Incidence of hypercalcemia ( defined as corrected serum calcium>10.5mg/dl) 3) Incidence of secondary hyperparathyroidism (defined as i-PTH>240pg/ml) 4) Performance rate of PTx and PEIT 5) BAP(ALP), i-PTH, BAP/i-PTH 6) Arterial stiffness change (CAVI, PWV, ABI) 7) Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Lanthanum carbonate treatment (Enrollment: 1 year, Follow-up: 3 years, Extension period: 2 years)
Interventions/Control_2	Calcium carbonate treatment ((Enrollment: 1 year, Follow-up: 3 years, Extension period: 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Hemodialysis patients 2) SerumP>6.0mg/dl and taking Phosphate binder in Hyperphosphosphataemia. 3) Hemodialysis for more than 6 mo, less than 5 years 4) Men or women >=20 years of age 5) Patients with written IC
Key exclusion criteria	1) Contraindications to Ca carbonate and La carbonate 2) Severe GI disorders 3) History of obstructed bowels 4) History of IHD/stroke within 6 mo before randomization 5) Severe congestive heart failure 6) Severe liver dysfunction (AST or ALT greater than 3 times the upper limit of normal, hepatic cirrhosis) 7) Severe malnutrition 8) Malignancy of any type within the last five years 9) Severe infectious disease within 3 mo before randomization 10) Pregnant or possibly pregnant women and women on lactation 11) Ineligible patients according to the investigators judgment
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Hiromichi Middle name Last name Suzuki
Organization	Saitama Medical School
Division name	Department of Nephrology
Zip code	350-0495
Address	38 Morohongo Moroyama-machi, Iruma-gun, Saitama, Japan
TEL	+81-49-276-1612
Email	iromichi@saitama.ac.jp

Public contact
Name of contact person	1st name Hiromichi Middle name Last name Suzuki
Organization	Saitama Medical School
Division name	Department of Nephrology
Zip code	350-0495
Address	38 Morohongo Moroyama-machi, Iruma-gun, Saitama, Japan
TEL	+81-49-276-1612
Homepage URL
Email	iromichi@saitama.ac.jp

Sponsor
Institute	Department of Nephrology
Institute
Department

Funding Source
Organization	Saitama Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Saitama Medical University
Address	38 Morohongo, Moroyama-machi,Iruma-gun, Saitama
Tel	0492761354
Email	hirb@saitama-med.ac.jp

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	埼玉医科大学病院　入間台クリニック　岡病院　武蔵嵐山病院　くぼしまクリニック

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 30 Day

Related information
URL releasing protocol	Information other than what is described on this site is not open to the public.
Publication of results	Unpublished

Result
URL related to results and publications	Information other than what is described on this site is not open to the public.
Number of participants that the trial has enrolled
Results	No result
Results date posted	2019 Year 12 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	No participants
Participant flow	No participants
Adverse events	None
Outcome measures	None
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 04 Month 21 Day
Date of IRB	2011 Year 07 Month 01 Day
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2013 Year 06 Month 01 Day
Date of closure to data entry	2013 Year 09 Month 01 Day
Date trial data considered complete	2013 Year 09 Month 01 Day
Date analysis concluded	2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2011 Year 04 Month 21 Day
Last modified on	2019 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006504