UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013978 |
|---|---|
| Receipt number | R000016158 |
| Scientific Title | Lanthanum carbonate impacts on calcification regulating factors in chronic kidney disease |
| Date of disclosure of the study information | 2014/05/31 |
| Last modified on | 2019/01/31 18:35:04 |
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Basic information
Public title
Lanthanum carbonate impacts on calcification regulating factors in chronic kidney disease
Acronym
MBD-CRF study
Scientific Title
Lanthanum carbonate impacts on calcification regulating factors in chronic kidney disease
Scientific Title:Acronym
MBD-CRF study
Region
| Japan |
Condition
Condition
Outpatients with chronic kidney disease stage 3-5 in department of medicine, Kidney Center of Tokyo Women's Medical University
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of lanthanum carbonate versus calcium carbonate on calcium regulating factors in chronic kidney disease stage 3-5
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Comparison of serum Fetuin-A levels between two groups treated with lanthanum carbonate and calcium carbonate
Key secondary outcomes
Serum levels of phosphate, calcium, intact PTH, high sensitive CRP, FGF23, Klotho, calcium protein particle, matrix gla protein, osteoprotegerin, osteopontin, Apo B48, MDA-LDL, and pentraxin 3.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lanthanum carbonate is administered for 12 weeks. Dose of lanthanum carbonate is 750-2250 mg/day. Lanthanum carbonate is administered 3 times/day.
Interventions/Control_2
Calcium carbonate is administered
for 12 weeks. Dose of calcium carbonate
is 3 g/day. Calcium carbonate is administered 3 times/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)Over 20 years old when informed concent
2)Chronic Kidney Disease stage 3-5(GFR<60 ml/min/1.73m2)
3)Patients over 3.0 mg/dL of serum phosphate levels and without treatments with phosphate binders
4)Patients who provided written concent to participate in this study after a sufficient explanation.
Key exclusion criteria
1)Patients who have a contraindication that is shown in the product documents of lanthanum carbonate or calcium carbonate.
2)Patients with malignant diseases or the possibility of maignant diseases of entry.
3)Patients with a past history of renal transplantation.
4)Pregnant women or women with possibility of pregnancy.
5)Patients who made a judgmental decision as an inadequate patient by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosaku Nitta |
Organization
Tokyo Women's Medical University
Division name
Department of Medicine, Kidney Center
Zip code
Address
8-1, Kawada-chou, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
knitta@kc.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukari Asamiya |
Organization
Tokyo Women's Medical University
Division name
Department of Medicine, Kidney Center
Zip code
Address
8-1, Kawada-chou, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Homepage URL
strawberry_age_order@yahoo.co.jp
Sponsor or person
Institute
Department of Medicine, Kidney Center, Tokyo Women's Medical University
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 31 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016158
