Iron Deficiency Anemia (IDA)Phase 2NCT07706582
Management of Iron Deficiency Anemia in Hemodialysis Patients
A Phase 2 study testing Lactoferrin and IV iron dextran in people with Iron Deficiency Anemia (IDA) and ESRD (End Stage Renal Disease), run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
- What is being tested?
- Lactoferrin and IV iron dextran
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2025to Jan 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged over 18
- Diagnosed with chronic kidney disease (CKD) on maintenance hemodialysis (3 sessions/week).
- Diagnosed with functional iron deficiency anemia
Who cannot join
- Active infection
- Inflammation (any cause other than CKD)
- Recent bleeding and recent blood transfusion
- Patients with decompensated medical conditions
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Theodor Bilharz Research Institute (TBRI)
Giza, El-Nile Street, Imbaba, Warrak El Hader
About this study
Official title: 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.
Read the 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
- Being tested
- Lactoferrin, IV iron dextran
- Medical subject headings
- Anemia, Iron-Deficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDietary supplement
oral Lactoferrin - dose : 100 mg twice daily ( total dose= 200 mg daily ) - duration: administered for three months
IV iron dextranDrug
IV Iron Dextran will be administered three times weekly for three months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Dietary Supplement: Lactoferrin; Drug: IV iron dextran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 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)
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
Measured: 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 )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start2 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia (IDA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Essam Albert, Beni-Suef University
- Investigators
- Marina E Albert, Bachelor of Pharmacy, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706582
- Sponsor's protocol ID
- PT (972)
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No