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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025478
Receipt No. R000029320
Scientific Title Clinical evaluation of the effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia
Date of disclosure of the study information 2016/12/31
Last modified on 2019/10/16

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Basic information
Public title Clinical evaluation of the effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia
Acronym The effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia
Scientific Title Clinical evaluation of the effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia
Scientific Title:Acronym The effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia
Region
Japan

Condition
Condition End stage kidney disease with renal and iron deficiency anemia and hyperphosphatemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effect of ferric citrate hydrate in hemodialysis patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes After 52 weeks
1. The rate of the accomplishment of the target of IP(3.5~6.0mg/dl)
2. The rate of the accomplishment of the target of Hb(10~12g/dl) and the average
3. Dose of ferric citrate hydrate
Key secondary outcomes 1. Fe Ferritin TSAT
2. cCa
3. Alb
4. hsCRP
5. BNP
6. Hb cyclimg
7. side effect
8. Dose of ESA

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oral administration of ferric citrate hydrate for 52weeks
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Iron deficiency anemia
TSAT<20%,Ferritin<100ng/ml
Key exclusion criteria History of hypersensitivity to ferric citrate
Intake of other Iron-contained drugs
digestive hemorrhage or IBD patient
pregnancy or planned pregnancy
malignancy
physician's decision
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Soejima
Organization Saiseikai Kumamoto Hospital
Division name kidney and urology center
Zip code
Address Chikami 5-3-1,Minami-ku, Kumamoto
TEL 096-351-8000
Email hironobu-inoue@saiseikaikumamoto.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Inoue
Organization Saiseikai Kumamoto Hospital
Division name kidney and urology center
Zip code
Address Chikami 5-3-1,Minami-ku, Kumamoto
TEL 096-351-8000
Homepage URL
Email hironobu-inoue@saiseikaikumamoto.jp

Sponsor
Institute Saiseikai Kumamoto Hospital
Institute
Department

Funding Source
Organization Saiseikai Kumamoto Hospital
Organization
Division
Category of Funding Organization Self funding
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 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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 12 Month 16 Day
Date of IRB
2016 Year 04 Month 01 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 30 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029320

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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