- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07706582
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
El-Nile Street, Imbaba, Warrak El Hader
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Giza, El-Nile Street, Imbaba, Warrak El Hader, Egypten
- Theodor Bilharz Research Institute (TBRI)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
oral Lactoferrin - dose : 100 mg twice daily ( total dose= 200 mg daily ) - duration: administered for three months
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Aktiv komparator: IV Iron Arm
The IV Iron arm (36 participants) will receive IV Iron therapy ( Iron Dextran) three times weekly with ESA for three months
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IV Iron Dextran will be administered three times weekly for three months
|
|
Aktiv komparator: 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.
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oral Lactoferrin - dose : 100 mg twice daily ( total dose= 200 mg daily ) - duration: administered for three months
IV Iron Dextran will be administered three times weekly for three months
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Measure the change in hemoglobin concentration (g/dL) from baseline to 3 months, assessing the efficacy of lactoferrin in correcting anemia.
Tidsramme: 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)
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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 )
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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)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
-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)
Tidsramme: 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 )
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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
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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 )
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Marina E Albert, Bachelor of Pharmacy, Beni-Suef University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Metaboliske sygdomme
- Hæmatologiske sygdomme
- Nyreinsufficiens
- Anæmi
- Forstyrrelser i jernmetabolisme
- Anæmi, hypokromisk
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Hemiske og lymfatiske sygdomme
- Jernmangel
- Nyreinsufficiens, kronisk
- Anæmi, jernmangel
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kemikalier
- Kulhydrater
- Hydrolaser
- Enzymer
- Enzymer og coenzymer
- Globuliner
- Koordinationskomplekser
- Polysaccharider
- Glycoproteiner
- Glycoconjugates
- Glukaner
- Endopeptidaser
- Peptidhydrolaser
- Serinendopeptidaser
- Serinproteaser
- Diætproteiner
- Mælkeproteiner
- Animalproteiner, kost
- Bærerproteiner
- Transferrins
- Jernbindende proteiner
- Lactoglobuliner
- Valleproteiner
- Metalloproteiner
- Dextrans
- Lactoferrin
- Jern-Dextran kompleks
Andre undersøgelses-id-numre
- PT (972)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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