Status:
COMPLETED
Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients
Lead Sponsor:
Centre Hospitalier Hassan II - Fès
Conditions:
Anemia of Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study aims to assess the comparative effects of intravenous and liposomal oral iron on hemoglobin levels in non-dialysis CKD patients. Additionally, it seeks to evaluate the rate of hemoglobin co...
Detailed Description
The last two and a half decades have seen erythropoiesis-stimulating agents (ESAs) and iron therapy at the forefront of managing anemia in chronic kidney disease (CKD) patients. While ESAs have demons...
Eligibility Criteria
Inclusion
- Inclusion criteria for the study are age \>18 years, eGFR ≤60 mL/min/1.73 m2 (Modification of Diet in Renal Disease equation: MDRD), Hb levels ≤12 g/dL, ferritin levels ≤100 ng/mL, transferrin saturation (TSAT) ≤25%, parathormone (PTH) serum levels between 30 and 300 pg/mL.
Exclusion
- Exclusion criteria included presence of an inflammatory or infectious disease with a C-reactive protein (CRP) levels ≥6 mg/L at the beginning of the study ,surgical interventions in the last 3 months, hematological disorders including bleeding or blood transfusions in the last 6 months, malignancies, ongoing treatment with immunosuppressive drugs, severe malnutrition (BMI\<20Kg/m² ; Albuminemia \<32 g/L with normal values of C-reactive protein (CRP); Decrease in weight \>5% in 1 month or \>7.5% in 3 months), history of major CVD (Myocardial Infarction, Chronic Heart Failure, Stroke), chronic alcohol abuse, known hepatitis B or C infection, pregnant or lactating women, and need to start dialysis.
- Withdrawal from the study occurs in the case of severe anemia needing an urgent blood transfusion or non-adherence and withdrawal of consent.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06556134
Start Date
July 1 2021
End Date
January 10 2024
Last Update
August 15 2024
Active Locations (1)
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1
Nephrology, Dialysis, and Transplantation, Hassan II University Hospital
Fes, Fès-Meknes, Morocco, 30050