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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030503
Receipt No. R000034815
Scientific Title The study about the effect of combination therapy of active form of vitamin D and lanthanum carbonate for serum concentration of FGF23
Date of disclosure of the study information 2018/01/20
Last modified on 2017/12/21

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Basic information
Public title The study about the effect of combination therapy of active form of vitamin D and lanthanum carbonate for serum concentration of FGF23
Acronym CVD-LAF study
Scientific Title The study about the effect of combination therapy of active form of vitamin D and lanthanum carbonate for serum concentration of FGF23
Scientific Title:Acronym CVD-LAF study
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to investigate the effect of usual amount of active form of vitamin D in clinical situation with or without lanthanum carbonate for serum FGF23 level and cardiovascular system.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes change of serum FGF23 level after 24 weeks
Key secondary outcomes changes of laboratory data including other bone metabolic markers, results of echocardiogram, changes of aortic calcification score, amounts of active form of vitamin D or lanthanum carbonate

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 Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The period of treatment of patients randomized to active form of vitamin D group is 52 weeks.
The initial dose of active form of vitamin D, which is alphacalcidol, is 0.25 microgram/day or 0.5 microgram/day, if serum corrected calcium concentration is from 9.0 to 9.5 mg/dl, or less than 9.0 mg/dl, respectively. Investigators control dose of alphacalcidol to set serum corrected calcium level to >=8.5 mg/dl and < 10.0 mg/dl.
Interventions/Control_2 The period of treatment of patients randomized to combination of active form of vitamin D and lanthanum carbonate group is 52 weeks.
The initial dose of active form of vitamin D, which is alphacalcidol, is 0.25 microgram/day or 0.5 microgram/day, if serum corrected calcium concentration is from 9.0 to 9.5 mg/dl, or less than 9.0 mg/dl, respectively. Moreover the initial dose of lanthanum carbonate is 750 mg/day. Investigators control dose of alphacalcidol to set serum corrected calcium level to >=8.5 mg/dl and <10.0 mg/dl. In addition, investigators control dose of lanthanum carbonate to set serum phosphate level to >=3.5 mg/dl and < 6.0 mg/dl.
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 We include patients who meet conditions below:
1. eGFR is >=10 and < 45 ml/min/1.73m2
2. serum corrected calcium level is less than 9.5 mg/dL
3. serum phosphate level is >=4 and < 6 mg/dL
4. serum intact PTH level is >=60 pg/mL
Key exclusion criteria We exclude patients who meet conditions below:
1. patients who have taken active form of vitamin D within 4 weeks.
2. patients who have taken any supplements including natural form of vitamin D within 4 weeks.
3. patients who have taken any phosphate binders within 4 weeks.
4. patients who do not agree with the study
5. patients whom one or more investigators do not regard as appropriate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daijo Inaguma
Organization Fujita Health University
Division name Department of Nephrology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9245
Email daijo@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daijo Inaguma
Organization Fujita Health University
Division name Department of Nephrology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9245
Homepage URL
Email daijo@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Clinical research support center of Fujita Health University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 藤田保健衛生大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 20 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 20 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
2017 Year 12 Month 21 Day
Last modified on
2017 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034815

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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