Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922645
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2021-06-08
Brief Title:
Auryxia Ferric Citrate Therapy for In-Center and Home Dialysis Participants
Sponsor:
USRC Kidney Research
Organization:
USRC Kidney Research
Study Overview
Official Title:
A Multicenter Randomized Open-label Active-controlled Study to Assess the Impact of Auryxia Ferric Citrate on Erythropoiesis-Stimulating Agent ESA Use Intravenous IV Iron Use Phosphate Control and Anemia Control in Adult Participants on In-Center Hemodialysis or Home Dialysis
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT
Brief Summary:
This study is being conducted to demonstrate the effect of Auryxia when used as the primary phosphate lowering therapy on the overall cumulative use of erythropoiesis-stimulating agent and intravenous iron as well as on the laboratory parameters indicative of phosphate and anemia management
Detailed Description:
Approximately 200 participants will be randomized 11 stratified by modality and hemoglobin level to receive either Auryxia or standard of care phosphate lowering therapy to determine the impact of Auryxia when used as the primary phosphate lowering therapy as compared to standard of care on the utilization of erythropoiesis-stimulating agent and intravenous iron in both in-center and home dialysis populations This study will also seek to determine the impact of Auryxia when used as the primary phosphate lowering therapy versus standard of care on the biochemical assessments of serum phosphate and hemoglobin in both in-center and home dialysis populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None