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Recruitment status Completed
Unique ID issued by UMIN UMIN000013978
Receipt No. 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

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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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Last 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
Email knitta@kc.twmu.ac.jp

Public contact
1st 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
Email strawberry_age_order@yahoo.co.jp

Sponsor
Institute Department of Medicine, Kidney Center, Tokyo Women's Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016158


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