UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study to evaluate effect of ferric citrate hydrate on oxidative-stress in maintenance hemodialysis patients.
Title of the study (Brief title)	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	Masaaki Nakayama
Organization	Fukushima Medical University
Division name	Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-547-1217
Email	masanaka@fmu.ac.jp

Public contact
Name of contact person	Masaaki Nakayama
Organization	Fukushima Medical University
Division name	Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-547-1217
Homepage URL
Email	masanaka@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023889