UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020935 |
|---|---|
| Receipt number | R000024151 |
| Scientific Title | A prospective study for the effect of ferric citrate on FGF23 in patients with normophosphatemic CKD patients with iron deficiency. |
| Date of disclosure of the study information | 2016/02/09 |
| Last modified on | 2017/03/23 16:52:42 |
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Basic information
Public title
A prospective study for the effect of ferric citrate on FGF23 in patients with normophosphatemic CKD patients with iron deficiency.
Acronym
the effect of ferric citrate on FGF23
Scientific Title
A prospective study for the effect of ferric citrate on FGF23 in patients with normophosphatemic CKD patients with iron deficiency.
Scientific Title:Acronym
the effect of ferric citrate on FGF23
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine FGF23 of ferric citrate hydrate and sodium ferrous citratein normophosphatemic CKD patient with iron deficiency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum FGF23 concentration(after 1 month, 3 months)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ferric citrate hydrate 750mg/day 3months
Interventions/Control_2
sodium ferrous citrate 50mg/day 3months
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) eGF<45
3) The patients whom Phosphate level is under 4.5 mg/dL
4)iron deficiency (1.ferritin<100pg/ml or 2.100<ferritin<300ng/ml and TSAT<20%)
5) documented informed concent
Key exclusion criteria
1)treatment with phosphate binder or iron supplementation
2) hypersensitivity to lanthanum carbonate and calcium carbonate
3) pregnancy or lactation
4) 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 | Akira Iguchi |
Organization
Saiseikai Niigata Daini Hospital
Division name
Division of Clinical Nephrology and Rheumatology
Zip code
Address
280-7 Teraji, Niigata 950-1104, Japan
TEL
025-233-6161
igucci4444@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Iguchi |
Organization
Saiseikai Niigata Daini Hospital
Division name
Division of ClinicaNephrology and Rheumatology
Zip code
Address
280-7 Teraji, Niigata 950-1104, Japan
TEL
025-233-6161
Homepage URL
igucci4444@yahoo.co.jp
Sponsor or person
Institute
Department of Nephrology and Rheumatology, Saiseikai Niigata Daini Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology and Rheumatology, Saiseikai Niigata Daini Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 09 | 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
| 2015 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 09 | 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
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024151
