UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020702 |
|---|---|
| Receipt number | R000023889 |
| Scientific Title | Exploratory study to evaluate effect of ferric citrate hydrate on oxidative-stress in maintenance hemodialysis patients. |
| Date of disclosure of the study information | 2016/01/22 |
| Last modified on | 2017/07/04 17:20:29 |
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Basic information
Public title
Exploratory study to evaluate effect of ferric citrate hydrate on oxidative-stress in maintenance hemodialysis patients.
Acronym
Exploratory study to evaluate effect of ferric citrate hydrate on oxidative-stress.
Scientific Title
Exploratory study to evaluate effect of ferric citrate hydrate on oxidative-stress in maintenance hemodialysis patients.
Scientific Title:Acronym
Exploratory study to evaluate effect of ferric citrate hydrate on oxidative-stress.
Region
| Japan |
Condition
Condition
Maintenance hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the expression changes of oxidative-stress markers, etc. after administrating a single dose of ferric citrate hydrate to maintenance hemodialysis patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) To compare the time-course differences of oxidative stress related markers between cases with oral administration of single dose ferric citrate hydrate and those with intravenous administration of single dose Saccharated Ferric Oxide.
2) To compare the time-course differences of iron related parameters between cases with oral administration of single dose ferric citrate hydrate and those with intravenous administration of single dose Saccharated Ferric Oxide.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) Ferric citrate hydrate is orally administered at a dose of 2g only once during period of the trial immediately after beginning hemodialysis at the maximum interval.
2) At a week after the administration described above, intravenous iron agent is administered at a dose of 40mg only once during period of the trial immediately after beginning hemodialysis.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Japanese patients aged over 20 years old.
2) Patients stably receiving hemodialysis three times a week from more than 12 weeks before the beginning of the trial.
3) Difference between recent measured values of Hb is within 1g/dL in the laboratory data which is taken without 4 weeks prior to the beginning of the trial.
4) As indicated below in the case of patients under the treatment with ESA.
Patients receiving a constant dose of ESA without changing the type of ESA for at least 2 weeks prior to the beginning of the trial.
5) Patients who provided voluntary informed consent to participate in the trial.
Key exclusion criteria
1) Patients whose serum ferritin level is more than 300 ng/mL according to the laboratory data which is taken without 12 weeks prior to the beginning of the trial.
2) Patients who received intravenous iron agents within 4 weeks prior to the beginning of the trial.
3) Patients who received oral iron agents within 2 weeks before the beginning of the trial.
4) Patients who received blood transfusion therapy within 12 weeks prior to the beginning of the trial.
5) Patients who are pregnant or breastfeeding.
6) Patients with a history of gastrectomy or duodenectomy.
7) Current smokers.
8) Patients with acute or severe chronic inflammatory condition.
9) Patients with active infection.
10) Patients with uncontrolled hypertension or diabetes.
11) Patients with cardiac or cerebrovascular disease.
12) Patients with malignancy (including hematological malignancy), or with a history of malignancy within 5 years prior to registration.
13) Patients judged as inappropriate candidates for the trial by the investigators.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Nakayama |
Organization
Fukushima Medical University
Division name
Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1217
masanaka@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Nakayama |
Organization
Fukushima Medical University
Division name
Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1217
Homepage URL
masanaka@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Tobacco Inc.
Torii Pharmaceutical 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
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 | 01 | Month | 22 | 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 | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | 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 | 01 | Month | 22 | Day |
Last modified on
| 2017 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023889
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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