UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025478 |
|---|---|
| Receipt number | 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 15:58:59 |
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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
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
hironobu-inoue@saiseikaikumamoto.jp
Sponsor or person
Institute
Saiseikai Kumamoto Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029320
