UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006808 |
|---|---|
| Receipt number | 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 14:24:50 |
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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
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
fhideki@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of nephrology & kidney center, Kobe university graduate school of medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007749
