- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
El-Nile Street, Imbaba, Warrak El Hader
-
Giza, El-Nile Street, Imbaba, Warrak El Hader, Egitto
- Theodor Bilharz Research Institute (TBRI)
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
|
|
Comparatore attivo: IV Iron Arm
The IV Iron arm (36 participants) will receive IV Iron therapy ( Iron Dextran) three times weekly with ESA for three months
|
IV Iron Dextran will be administered three times weekly for three months
|
|
Comparatore attivo: 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.
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Measure the change in hemoglobin concentration (g/dL) from baseline to 3 months, assessing the efficacy of lactoferrin in correcting anemia.
Lasso di tempo: 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)
|
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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
-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)
Lasso di tempo: 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 )
|
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 )
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Marina E Albert, Bachelor of Pharmacy, Beni-Suef University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Processi patologici
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattia cronica
- Attributi della malattia
- Malattie metaboliche
- Malattie ematologiche
- Insufficienza renale
- Anemia
- Disturbi del metabolismo del ferro
- Anemia, ipocromica
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Malattie emiche e linfatiche
- Carenze di ferro
- Insufficienza renale cronica
- Anemia, carenza di ferro
- Aminoacidi, peptidi e proteine
- Proteine
- Prodotti chimici organici
- Carboidrati
- Idrolasi
- Enzimi
- Enzimi e coenzimi
- Globuline
- Complessi di coordinamento
- Polisaccaridi
- Glicoproteine
- Glicoconiugati
- Glucani
- Endopeptidasi
- Idrolasi peptidiche
- Endopeptidasi serina
- Proteasi di serina
- Proteine dietetiche
- Proteine del latte
- Proteine animali, dieta
- Proteine portanti
- Transferri
- Proteine leganti il ferro
- Lattoglobuline
- Proteine del siero di latte
- Metalloproteine
- Dextrans
- Lattoferrina
- Complesso Ferro-Destrano
Altri numeri di identificazione dello studio
- PT (972)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .