Exploratory study to evaluate effect of ferric citrate hydrate on oxidative-stress in maintenance hemodialysis patients.

Not Applicable

• Conditions: Maintenance hemodialysis patients

• Registration Number: JPRN-UMIN000020702
• Lead Sponsor: Fukushima Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.