drugset / Trial / NCT07706582

Management of Iron Deficiency Anemia in Hemodialysis Patients

NCT07706582

Phase 2 Active not recruiting 108 enrolled Beni-Suef University
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this interventional study is to assess the effectiveness of oral lactoferrin in improving hemoglobin levels and correcting iron deficiency anemia in patients with end-stage renal disease (ESRD) on dialysis and also evaluate the impact of lactoferrin on bone health by measuring serum calcium and phosphate and other bone health indicators. The participants will be divided into 3 groups as follow * The Lactoferrin group will receive treatment of oral lactoferrin at a dose of 100 mg twice daily alongside erythropoiesis-stimulating agent (ESA) therapy for three months. * The IV Iron group will receive IV Iron therapy with ESA for the same duration * The Lactoferrin + IV Iron group will receive both oral lactoferrin at a dose of 100 mg twice daily and IV Iron therapy alongside erythropoiesis-stimulating agent (ESA) therapy for three months.

Timeline

Start
2025-11-02
Primary completion
2026-09
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Iron dextran Unknown Intravenous
Subject Lactoferrin Protein / enzyme biologic 100 mg Oral