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Active Not Recruiting NCT07706582

Management of Iron Deficiency Anemia in Hemodialysis Patients

Conditions: Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)

Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 108
Sponsor: Beni-Suef University

Location: Theodor Bilharz Research Institute (TBRI) Giza El-Nile Street, Imbaba, Warrak El Hader

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.

Eligibility Criteria

Inclusion Criteria: * Adult patients aged over 18 * Diagnosed with chronic kidney disease (CKD) on maintenance hemodialysis (3 sessions/week). * Diagnosed with functional iron deficiency anemia Exclusion Criteria: * Active infection * Inflammation (any cause other than CKD) * Recent bleeding and recent blood transfusion * Patients with decompensated medical conditions

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07706582). StuddyBuddy aggregates publicly available trial information.