Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521216
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-01
Brief Title:
Different Oral Iron Dosing Regimens in Treatment of Iron Deficency Anemia in Patients With Chronic Kidney Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing Different Oral Iron Dosing Regimens in Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Comparing between the efficacy of alternate day oral iron dose once daily and thrice daily dose in improving anemia in CKD patients
Detailed Description:
Anemia is common in chronic kidney disease CKD and has been associated with impaired quality of life cardiovascular disease CVD and mortality
Iron deficiency is common in patients with CKD and an important modifiable factor in treatment of anemia
In particular the Kidney Disease Improving Global Outcomes KDIGO anemia work group guidelines define anemia in CKD as a hemoglobin concentration of 130 gdL in men and 120 gdL in women The current guidelines recommend trial of iron supplementation in CKD when increase in hemoglobin concentration or decrease in erythropoietin dose is desired and investigations reveal percentage transferrin saturation TSAT 30 and serum ferritin 500 ngml
The absorption of iron from gastro-intestinal tract and release of iron from reticuloendothelial cells for erythropoiesis are tightly regulated through hepcidin-ferroportin axis Hepcidin concentrations increase in response to iron excess and inflammation CKD is associated with elevated hepcidin and ferritin concentrations due to underlying inflammation independent of iron status
Iron-deficiency anemia in individuals with CKD may result from functional iron deficiency absolute iron deficiency or both The factors contributing to functional iron deficiency are chronic inflammation and poor hepcidin clearance seen in CKD whereas absolute iron deficiency includes poor gastrointestinal GI dietary iron absorption and blood loss
In patients with CKD who are not on dialysis oral route may be preferred as initial mode of iron supplementation Oral iron is inexpensive self-administered convenient and easily available
Three different oral iron supplement strategies-once daily multidose per day and alternate-day dose-improve hemoglobin Hgb and iron indices in patients with iron deficiency anemia and chronic kidney disease CKD
Study showed that daily doses of oral iron reduced its absorption by increasing serum hepcidin levels This study also found that administration of oral iron on alternate days as single doses improved iron absorption
Theoretically using lower doses and increasing time interval between consecutive doses might reduce the amount of unabsorbed iron in the gastrointestinal tract resulting in lesser gastrointestinal side effects However the major concern with alternate day dosing is that only half the total amount of iron is supplemented per unit time compared to daily dosing
More recent data suggest that lower doses and infrequent administration may be as effective as the traditional regimen while probably associated with lower rates of adverse effects
Investigators will investigate the effect of every other day once daily and three times a day dosing of oral iron formulation on measures of iron sufficiency in patients with stages 23 and 4 CKD through a randomized controlled trial
Iron deficiency is common in patients with CKD and an important modifiable factor in treatment of anemia
In particular the Kidney Disease Improving Global Outcomes KDIGO anemia work group guidelines define anemia in CKD as a hemoglobin concentration of 130 gdL in men and 120 gdL in women The current guidelines recommend trial of iron supplementation in CKD when increase in hemoglobin concentration or decrease in erythropoietin dose is desired and investigations reveal percentage transferrin saturation TSAT 30 and serum ferritin 500 ngml
The absorption of iron from gastro-intestinal tract and release of iron from reticuloendothelial cells for erythropoiesis are tightly regulated through hepcidin-ferroportin axis Hepcidin concentrations increase in response to iron excess and inflammation CKD is associated with elevated hepcidin and ferritin concentrations due to underlying inflammation independent of iron status
Iron-deficiency anemia in individuals with CKD may result from functional iron deficiency absolute iron deficiency or both The factors contributing to functional iron deficiency are chronic inflammation and poor hepcidin clearance seen in CKD whereas absolute iron deficiency includes poor gastrointestinal GI dietary iron absorption and blood loss
In patients with CKD who are not on dialysis oral route may be preferred as initial mode of iron supplementation Oral iron is inexpensive self-administered convenient and easily available
Three different oral iron supplement strategies-once daily multidose per day and alternate-day dose-improve hemoglobin Hgb and iron indices in patients with iron deficiency anemia and chronic kidney disease CKD
Study showed that daily doses of oral iron reduced its absorption by increasing serum hepcidin levels This study also found that administration of oral iron on alternate days as single doses improved iron absorption
Theoretically using lower doses and increasing time interval between consecutive doses might reduce the amount of unabsorbed iron in the gastrointestinal tract resulting in lesser gastrointestinal side effects However the major concern with alternate day dosing is that only half the total amount of iron is supplemented per unit time compared to daily dosing
More recent data suggest that lower doses and infrequent administration may be as effective as the traditional regimen while probably associated with lower rates of adverse effects
Investigators will investigate the effect of every other day once daily and three times a day dosing of oral iron formulation on measures of iron sufficiency in patients with stages 23 and 4 CKD through a randomized controlled trial
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