UMIN-CTR Clinical Trial

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)
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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
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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
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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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