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Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients: A Non-Inferiority Study
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 correction, iron reserve status during treatment, and therapeutic tolerance to these interventions.
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 demonstrated significant efficacy in alleviating anemia in this context, recent large-scale randomized controlled trials in both non-dialysis and dialysis CKD patients have shed light on their limitations. Attempts to normalize hemoglobin (Hb) levels with ESAs have shown no significant cardiovascular benefits but have been associated with increased risks of adverse events such as stroke and venous thromboembolism. Consequently, there has been a reduction in ESA prescription and an increase in blood transfusions, coupled with a notable rise in the use of iron therapy due to its role in addressing hypo responsiveness to ESAs. Anemia stands as a common complication in CKD, significantly impacting cardiovascular health and quality of life. While renal erythropoietin production deficit remains a primary cause, iron deficiency plays a pivotal role in CKD-related anemia genesis. Iron deficiency, whether absolute or functional, alongside an inflammatory block, often seen in CKD patients, accounts for the main reasons behind hypo responsiveness to erythropoiesis-stimulating agents. The recent shift in focus from ESA-centered treatment to iron therapy has prompted debates regarding the ideal route of iron administration, particularly in non-dialysis CKD patients. Despite the benefits of oral iron-cost-effectiveness and ease of administration-its usage remains limited due to poor gastrointestinal absorption and high adverse event rates. Conversely, concerns about IV iron revolve around potential kidney damage, infections, atherosclerosis promotion, and other adverse reactions. Given these considerations, our study aims to compare the efficacy of oral liposomal iron against IV iron in treating anemia in non-dialysis CKD patients in terms of : 1. Martial status under treatment. 2. Hemoglobin level and its correction speed. 3. Therapeutic tolerance.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Nephrology, Dialysis, and Transplantation, Hassan II University Hospital
Fes, Fès-Meknes, Morocco
Start Date
July 1, 2021
Primary Completion Date
July 1, 2023
Completion Date
January 10, 2024
Last Updated
August 15, 2024
27
ACTUAL participants
Intravenous Iron Sucrose
DRUG
Oral Iron
DRUG
Lead Sponsor
Centre Hospitalier Hassan II - Fès
NCT05515367
NCT05082584
Data Source & Attribution
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