Management of Iron Deficiency Anemia in Hemodialysis Patients

NCT07706582 | Active Not Recruiting Phase 2

• 1 other identifier: PT (972)
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron Deficiency Anemia (IDA); ESRD (End Stage Renal Disease)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• -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)

  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 )

Study Arms (3)

Lactoferrin Arm

ACTIVE COMPARATOR

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

IV Iron Arm

ACTIVE COMPARATOR

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

Lactoferrin + IV Iron Arm

ACTIVE COMPARATOR

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; Drug: IV iron dextran

Interventions

Lactoferrin DIETARY_SUPPLEMENT

oral Lactoferrin - dose : 100 mg twice daily ( total dose= 200 mg daily ) - duration: administered for three months

Lactoferrin + IV Iron Arm; Lactoferrin Arm

IV iron dextran DRUG

IV Iron Dextran will be administered three times weekly for three months

IV Iron Arm; Lactoferrin + IV Iron Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged over 18
• Diagnosed with chronic kidney disease (CKD) on maintenance hemodialysis (3 sessions/week).
• Diagnosed with functional iron deficiency anemia

You may not qualify if:

• Active infection
• Inflammation (any cause other than CKD)
• Recent bleeding and recent blood transfusion
• Patients with decompensated medical conditions

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Theodor Bilharz Research Institute (TBRI)

Giza, El-Nile Street, Imbaba, Warrak El Hader, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Renal Insufficiency, Chronic

Interventions

Lactoferrin; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins; Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides

Study Officials

• Marina E Albert, Bachelor of Pharmacy

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Candidate, Department of Clinical Pharmacy, Faculty of Pharmacy

Model Details: the study included 3 groups , the first group will receive oral lactoferrin 100mg twice daily alongside with erythropoiesis-stimulating agents (ESAs) for three months , the second group will receive IV Iron with ESAs for the same duration and the third group will receive both Lactoferrin and IV Iron with ESAs for the same duration

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 15, 2026
• Study Start: November 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)