UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016709 |
|---|---|
| Receipt number | 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 09:53:47 |
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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
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
snaito@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Department of Nephrology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019388
