Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556134
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Oral Liposomal Iron Versus Injectable Iron Sucrose for Anemia Treatment in Non-Dialysis Chronic Kidney Disease Patients A Non-Inferiority Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None