Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients

0107174

The aim of this study is to evaluate the effects of adding lactoferrin to the every-other-day oral iron supplementation in iron deficiency anemia and chronic kidney disease patients.

2022-10-01

2023-06-01

2023-09-01

Recruiting

Early phase I

60

Inclusion Criteria: 1. Males and Females aged ≥ 18 years old 2. Patients with eGFR ≥30 and ≤60 mL/min/1.73m2. 3. Absolute iron deficiency anemia (Hgb \<10g/dL, serum ferritin \<300ng/ml and Transferrin Saturation \< 30% ) Exclusion Criteria: 1. Patients on intermittent hemodialysis (IHD) 2. Patients with any known cause of anemia other than iron deficiency or CKD (e.g., sickle cell anemia) 3. Patients who received EPO 4 weeks ago 4. Patients who received IV Iron 8 weeks ago 5. Patients who received blood Transfusion 8 weeks ago 6. Current history of GI bleeding 7. Malignancy history 8. Pregnancy or lactation in female participants 9. Patients non-adherent to at least 80% of the regimen

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, open-labeled, parallel, randomised controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open labeled'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-06-12