Management of Iron Deficiency Anemia in Hemodialysis Patients

NCT07706582 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-07-20

No results posted yet for this study

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)

Interventions

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

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Principal Investigators

  • Marina E Albert, Bachelor of Pharmacy · Beni-Suef University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-02
Primary Completion
2026-09-30
Completion
2027-01-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706582 on ClinicalTrials.gov