Anemia of Chronic Kidney Disease
Conditions
Keywords
hemoglobin, transferrin saturation, ferritin, liposomal iron, intravenous iron sucrose
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 correction, iron reserve status during treatment, and therapeutic tolerance to these interventions.
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 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.
Interventions
Intravenous iron-hydroxide sucrose complex administered in a dose of 100 mg, diluted in 250 mL of normal saline, and infused weekly for a period of 3 months
DRUGOral Iron
One oral capsule per day, containing 30 mg of pyrophosphate liposomal iron and 70 mg of ascorbic acid
Sponsors
Centre Hospitalier Hassan II - Fès
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin elevation and its correction speed | Assessments were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5) | Clinical guidelines define a target hemoglobin range that indicates successful correction. Hemoglobin is measured in g/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ferritin serum levels | Assessments of ferritin levels were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5) | Ferritin levels, measured in ng/mL, serve as a reliable indicator of the body's iron reserves, reflecting overall iron storage. |
| Transferrin saturation | Assessments of transferrin saturation were conducted at baseline (Month 0) and during all subsequent follow-up visits at months 1 (Month 1), 2 (Month 2), and 3 (Month 3), as well as the 2 months following the drug discontinuation (Month 4) and (Month 5) | Transferrin saturation, expressed as a percentage (%), is a reliable indicator of iron availability in the body. The combination of ferritin levels (ng/mL) and transferrin saturation (%) provides the most reliable assessment of the body's iron status, offering a comprehensive view of both iron storage and availability. |
Countries
Morocco
Outcome results
None listed