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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016709
Receipt No. R000019388
Scientific Title A prospective randomized study for the effect of lanthanum carbonate on FGF23 in patients with chronic kidney disease at predialysis stage.
Date of disclosure of the study information 2015/03/10
Last modified on 2017/10/07

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Basic information
Public title A prospective randomized study for the effect of lanthanum carbonate on FGF23 in patients with chronic kidney disease at predialysis stage.
Acronym Effect of lanthanum carbonate on FGF23 in patients with CKD at predialysis stage.
Scientific Title A prospective randomized study for the effect of lanthanum carbonate on FGF23 in patients with chronic kidney disease at predialysis stage.
Scientific Title:Acronym Effect of lanthanum carbonate on FGF23 in patients with CKD at predialysis stage.
Region
Japan

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

Objectives
Narrative objectives1 We examine the clinical efficacy and FGF23 of lanthanum carbonate and calcium carbonate in CKD patient at predialysis stage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FGF23 at month 1, 2, 3, 4
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 lanthanum carbonate
Interventions/Control_2 calcium carbonate
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) outpatients
2) CKD stage G4 patients ( 15 < eGFR < 29 )
3) The patients whom Phosphate level is over 4.5 mg/dL
4) documented informed concent


Key exclusion criteria 1) Exclusion criteria were known hypersensitivity to lanthanum carbonate and calcium carbonate, and pregnancy or lactation.
2) Any reason for ineligibility suggested by the attending doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koju Kamata
Organization Kitasato University
Division name Department of Nephrology
Zip code
Address 1-15-1 kitasato, Minami-ku, Sagamihara, 252-0329
TEL 042-778-8111
Email kamatak@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shokichi Naito
Organization Kitasato University
Division name Department of Nephrology
Zip code
Address 1-15-1 kitasato, Minami-ku, Sagamihara, 252-0329
TEL 042-778-8111
Homepage URL
Email snaito@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Department of Nephrology
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization Profit organization
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 YES
Study ID_1 KMEO B14-866
Org. issuing International ID_1 Kitasato University Institutional Review Board for Clinical Research and Treatment
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 10 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 Terminated
Date of protocol fixation
2015 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
2017 Year 10 Month 02 Day
Date trial data considered complete
2017 Year 10 Month 02 Day
Date analysis concluded
2017 Year 10 Month 02 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 04 Day
Last modified on
2017 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019388

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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