UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020935
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email igucci4444@yahoo.co.jp

Sponsor
Institute Department of Nephrology and Rheumatology, Saiseikai Niigata Daini Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024151

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.