UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039788 |
|---|---|
| Receipt number | R000040002 |
| Scientific Title | Effect of ferric citrate for recovery from fatigue, phosphate binding, and iron supplementation in hemodialysis patients with well-controlled parathyroid hormone. -comparison with lanthanum carbonate- |
| Date of disclosure of the study information | 2020/03/13 |
| Last modified on | 2020/03/13 18:19:05 |
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Basic information
Public title
Effect of ferric citrate for recovery from fatigue, phosphate binding, and iron supplementation in hemodialysis patients with well-controlled parathyroid hormone. -comparison with lanthanum carbonate-
Acronym
Effect of ferric citrate for recovery from fatigue, phosphate binding capacity, and iron supplementation.
Scientific Title
Effect of ferric citrate for recovery from fatigue, phosphate binding, and iron supplementation in hemodialysis patients with well-controlled parathyroid hormone. -comparison with lanthanum carbonate-
Scientific Title:Acronym
Effect of ferric citrate for recovery from fatigue, phosphate binding capacity, and iron supplementation.
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of ferric citrate for recovery from fatigue.
Basic objectives2
Others
Basic objectives -Others
To evaluate the phosphate binding efficacy of ferric citrate.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The ammount of fatigue score change in questionnaire consisted of 64 questions at 2weeks after administartion of ferric citrate or lanthum carbonate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
intervention: ferric citrate 1500 mg/day, 3 months
Interventions/Control_2
control: lanthanum carbonate 1500 mg/day, 3 months
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)Hemodialysis patients
2)TSAT < 20 % and serum ferritin < 100 ng/mL
3)Serum intact-PTH 60-240 pg/mL
4)Hb 9.0-11.5 g/dL
5)Serum phosphate >6.0 mg/dL or taking phosphate binders except for ferric citrate and Sucroferric oxyhydroxide.
Key exclusion criteria
1)taking iron medication
2)malignancy, severe sepsis
3)gastrointestinal hemorrge
4)pregnant or possible pregnancy
5)Allergy to ferric citrate or lanthunum carbonate
6)Inappropriate patients regarded by doctor.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Tateishi |
Organization
Ishikiri Seiki Hospital
Division name
Department of Nephrology
Zip code
5798026
Address
18-28, yahoi-cho, Higasi-Osaka city, Osaka, Japan
TEL
072-988-3121
y-tateishi@ishikiriseiki.or.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tateishi |
Organization
Ishikiri Seiki Hospital
Division name
Department of Nephrology
Zip code
579-8026
Address
18-28, yahoi-cho, Higasi-Osaka city, Osaka, Japan
TEL
072-988-3121
Homepage URL
y-tateishi@ishikiriseiki.or.jp
Sponsor or person
Institute
Ishikiri Seiki Hospital
Institute
Department
Personal name
Funding Source
Organization
SB bioscience co. 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
Ishikiriseiki Hospital Institutional review board
Address
18-28, yahoi-cho, Higasi-Osaka city, Osaka, Japan
Tel
072-988-3121
webmaster@ishikiriseiki.or.jp
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
| 2020 | Year | 03 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040002
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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