UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005670 |
|---|---|
| Receipt number | R000005743 |
| Scientific Title | Randomized study of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification |
| Date of disclosure of the study information | 2011/05/30 |
| Last modified on | 2011/05/30 15:20:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized study of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification
Acronym
Randomized study of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification
Scientific Title
Randomized study of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification
Scientific Title:Acronym
Randomized study of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification
Region
| Japan |
Condition
Condition
Hemodialysis patients with hyperphosphatemia
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 patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
-Coronary artery calcification
-Major Adverse Cardiovascular Events
Key secondary outcomes
-Coronary stenosis
-Aortic valve/Mitral valve calcification
left ventricular ejection fraction
-Descending aorta calcification
-Pi and Ca level achievement rate as defined by local guideline
-Albmin, intact-PTH, ALP, hs-CRP
-Bone metabolism marker
-Bone density
-nPCR
-Adverse drug reaction
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lanthanum carbonate treatment for 2 year
Interventions/Control_2
Calcium carbonate treatment for 2 year
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
-Newly initiated hemodialysis patients
-Age >20 years old
-Ability to understand and willingness to sign a written Informed Consent
Key exclusion criteria
-Patients who will meet the contraindication according to package insert
-Severe GI disorders
-History of obstructed bowels
-Severe liver dysfunction
-Pregnant or possibly pregnant women and women on lactation
-Ineligible patients according to the investigator's judgment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MASAHITO TAMURA |
Organization
UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH
Division name
KIDNEY CENTER
Zip code
Address
1-1 Iseigaoka, Yahatanishi, Kitakyushu, Fukuoka 807-8556
TEL
093-603-1611
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MASAHITO TAMURA |
Organization
UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH
Division name
KIDNEY CENTER
Zip code
Address
1-1 Iseigaoka, Yahatanishi, Kitakyushu, Fukuoka 807-8556
TEL
093-603-1611
Homepage URL
http://www.uoeh-u.ac.jp/JP/index.html
mtamura@med.uoeh-u.ac.jp
Sponsor or person
Institute
UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH
Institute
Department
Personal name
Funding Source
Organization
Bayer Healthcare
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
産業医科大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | 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
| 2011 | Year | 05 | Month | 30 | Day |
Last modified on
| 2011 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005743
