Management of Iron Deficiency Anemia in Hemodialysis Patients

Evaluating the Therapeutic Impact of Lactoferrin on Complications in Patients With End-Stage Renal Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Iron Deficiency Anemia (IDA); ESRD (End Stage Renal Disease)
• Intervention / Treatment: Dietary supplement: Lactoferrin; Drug: IV iron dextran

Detailed Description

The goal of this clinical trial is to evaluate the therapeutic impact of oral Lactoferrin on correcting iron deficiency anemia and improving bone health in patients diagnosed with end-stage renal disease.

AS End-stage renal disease (ESRD) represents a serious medical, social, and economic burden on any society and requires continuous medical attention and comprehensive healthcare services. Without appropriate treatment, it can be life-threatening.

Anemia is a common complication in individuals with chronic kidney disease (CKD) and has been linked to negative cardiovascular outcomes . Managing anemia often involves the use of erythropoiesis-stimulating agents (ESAs); however, targeting normal hemoglobin levels through ESA therapy has been associated with a heightened risk of cardiovascular events and mortality. To achieve effective anemia control, iron supplementation alongside ESAs plays a crucial role. Iron therapy not only helps elevate hemoglobin levels, but also lowers the necessary dosage of ESAs . However, Iron One of the drawbacks of intravenous (IV) iron administration in hemodialysis patients is its potential link to an increased risk of infections, as suggested by some observational studies-though the evidence remains conflicting and inconclusive.

Lactoferrin, also known as the "red protein," is a cationic glycoprotein from the transferrin family with an exceptionally high affinity for iron-approximately 300 times greater than transferrin. Its red color results from this strong iron-binding property. Its production increases during infection and inflammation It contributes to intestinal iron regulation, enhances the body's defense against microbial infections, acts as an anti-inflammatory agent, Thus, and in contrast to iron therapy, lactoferrin offers several advantages over conventional iron supplements, including better gastrointestinal tolerance, fewer side effects associated with high-dose iron intake, and added anti-inflammatory and antimicrobial properties.

Another complication associated with patients with ESRD is Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), which is a complex, multifactorial condition characterized by disruptions in mineral metabolism, particularly involving calcium, phosphate, vitamin D and parathyroid hormone (PTH). Impaired kidney function leads to phosphate retention, decreased calcitriol synthesis, and calcium imbalance, triggering secondary hyperparathyroidism. Altogether, these hormonal and biochemical changes contribute to both skeletal complications and cardiovascular risks in CKD patients.

Lactoferrin also promotes bone growth by stimulating osteoblast proliferation, preventing cell death, and inhibiting osteoclast formation. These properties suggest its potential as a therapeutic agent for bone healing and osteoporosis Thus, the current study aims to assess the effect of lactoferrin use in patients with ESRD and receiving dialysis assessing its therapeutic potential in enhancing bone mineral density and correcting anemia in patients with chronic kidney disease

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lactoferrin Arm; The Lactoferrin Arm (36 participants) will receive a treatment of oral lactoferrin at a dose of 100 mg twice daily alongside Erythropoiesis-Stimulating Agent (ESA) therapy for three months.	Dietary supplement: Lactoferrin; oral Lactoferrin - dose : 100 mg twice daily ( total dose= 200 mg daily ) - duration: administered for three months
Active Comparator: IV Iron Arm; The IV Iron arm (36 participants) will receive IV Iron therapy ( Iron Dextran) three times weekly with ESA for three months	Drug: IV iron dextran; IV Iron Dextran will be administered three times weekly for three months
Active Comparator: Lactoferrin + IV Iron Arm; The Lactoferrin + IV Iron arm (36 participants) will receive both oral Lactoferrin 100 mg twice daily and IV Iron alongside ESA therapy for three months.	Dietary supplement: Lactoferrin; oral Lactoferrin - dose : 100 mg twice daily ( total dose= 200 mg daily ) - duration: administered for three months; Drug: IV iron dextran; IV Iron Dextran will be administered three times weekly for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the change in hemoglobin concentration (g/dL) from baseline to 3 months, assessing the efficacy of lactoferrin in correcting anemia.	Hemoglobin concentration (g/dL) will be measured using automated hematology analyzer as a part of routine complete blood count (CBC) by collecting blood samples at baseline ( before the intervention) and after 3 months ( after 12 week of drug administration or at the end of the study )	Hemoglobin concentration (g/dL) will be measured at baseline and after 3 months (after 12 week of drug administration or at the end of the study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
-Measure the change in other complete blood count parameters including Red Blood Cells, Hematocrit and Mean Corpuscular Volume. -Measure the change in Iron Profile and also in Bone health indicators (Serum calcium and phosphate)	Iron profile parameters will be measured after serum separation by centrifugation then serum iron and Total Iron Binding Capacity will be determined by automated colorimetric assay	All these parameters will be measured at baseline ( before the intervention) and also after three months (after 12 week of drug administration or at the end of the study )

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Marina E Albert, Bachelor of Pharmacy, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 11, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Hematologic Diseases; Renal Insufficiency; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Carbohydrates; Hydrolases; Enzymes; Enzymes and Coenzymes; Globulins; Coordination Complexes; Polysaccharides; Glycoproteins; Glycoconjugates; Glucans; Endopeptidases; Peptide Hydrolases; Serine Endopeptidases; Serine Proteases; Dietary Proteins; Milk Proteins; Animal Proteins, Dietary; Carrier Proteins; Transferrins; Iron-Binding Proteins; Lactoglobulins; Whey Proteins; Metalloproteins; Dextrans; Lactoferrin; Iron-Dextran Complex
• Other Study ID Numbers: PT (972)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No