This is a prospective multicenter randomized controlled clinical study. The goal of this clinical trial is to learn if intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets. The main questions to answer are: * Changes in hemoglobin concentration from baseline to week 8 after the use of single dose intravenous iron isomaltoside injection in peritoneal dialysis patients with renal anemia. * If intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets. Participants will: * be randomized 1:1 to two groups, either Iron isomaltoside Group (Group A, experimental group) or Ferrous succinate Group (Group B, control group). * Patients in Iron isomaltoside Group will receive a single dose of intravenous iron isomaltoside injection, the dose of which is set at 1000 mg. Patients in Ferrous succinate Group will receive ferrous succinate treatment orally given as 200mg twice a day for 8 weeks (containing iron element 7840mg in total). * Patients will be followed up for 8 weeks.
This is a prospective multicenter randomized controlled clinical study. The purpose of this study is to evaluate the efficacy and safety of single dose intravenous iron isomaltoside comparing with daily oral ferrous succinate in the treatment of renal anemia among patients on peritoneal dialysis. A total of 124 patients will be enrolled. The primary endpoint is hemoglobin change from baseline to week 8, the secondary endpoint is hemoglobin change from baseline to week 4. Other secondary endpoints include the results of iron metabolism, reticulocytes, composite cardiovascular events, laboratory and safety parameters. The expected result is that intravenous iron isomaltoside is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Intravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline.
Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks.
Changes in hemoglobin concentration from baseline to week 8
Full blood count
Time frame: Screening period,Day 1,Week 1,Week 4,Week 8
Changes in hemoglobin concentration from baseline to week 4
Full blood count
Time frame: Screening period,Day 1,Week 1,Week 4
Iron metabolism indices and reticulocyte count at week 8
Iron metabolism indices and reticulocyte count
Time frame: Screening period,Day 1,Week 1,Week 4,Week 8
Iron metabolism indices and reticulocyte count at week 4
Iron metabolism indices and reticulocyte count
Time frame: Screening period,Day 1,Week 1,Week 4
Compound cardiovascular adverse events at Week 8
Recording and observation with the reference of clinical symptoms and the results of EKG, NT-proBNP, cardiac troponin, CK-MB and myoglobin etc.
Time frame: Through study completion, an average of 1 year
Adverse Events
Recording and observation with the reference of clinical symptoms and the results of laboratory indices and other indices for safety
Time frame: Through study completion, an average of 1 year
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