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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035527
Receipt No. R000040476
Scientific Title Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
Date of disclosure of the study information 2019/01/13
Last modified on 2019/01/12

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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
Middle name
Last name Takayuki Hamano
Organization Osaka University Hospital
Division name Department of Nephrology
Zip code
Address 2-15, Yamada-oka, Suita, Osaka
TEL 06-6879-3857
Email hamatea@kid.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakaguchi Yusuke
Organization Osaka University Hospital
Division name Department of Nephrology
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2014 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 02 Day
Last follow-up date
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
2019 Year 01 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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