Maintenance hemodialysis patients
Conditions
Interventions
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 administ
Sponsors
Fukushima Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMasaaki Nakayama
Fukushima Medical University Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Outcome results
None listed