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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006808
Receipt No. R000007749
Scientific Title A randomized controlled trial of lanthanum carbonate versus calcium carbonate on coronary artery calcification in patients new to dialysis
Date of disclosure of the study information 2011/12/01
Last modified on 2017/10/30

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Basic information
Public title A randomized controlled trial of lanthanum carbonate versus calcium carbonate on coronary artery calcification in patients new to dialysis
Acronym Effect of lanthanum carbonate on coronary artery calcification in patients new to dialysis
Scientific Title A randomized controlled trial of lanthanum carbonate versus calcium carbonate on coronary artery calcification in patients new to dialysis
Scientific Title:Acronym 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
1st name
Middle name
Last name Shinichi Nishi
Organization Kobe university graduate school of medicine
Division name Division of nephrology and kidney Center
Zip code
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
1st name
Middle name
Last name Hideki Fujii
Organization Kobe university graduate school of medicine
Division name Division of nephrology and kidney center
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs00223-017-0347-3
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
2011 Year 12 Month 01 Day
Date of IRB
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

Other
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

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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