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NOT YET RECRUITING
NCT06830941
PHASE4

Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

Sponsor: Xie Jingyuan, MD

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy and Safety of Iron Isomaltoside in the Treatment of Peritoneal Dialysis Patients with Renal Related Anemia: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-02-15

Completion Date

2027-12-31

Last Updated

2025-02-17

Healthy Volunteers

No

Interventions

DRUG

Iron isomaltoside

Intravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline.

DRUG

Ferrous succinate

Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks.