Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants
IMPACT
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
1 other identifier
interventional
214
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2021
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedStudy Start
First participant enrolled
June 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedNovember 7, 2022
November 1, 2022
1.2 years
June 8, 2021
November 3, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Difference in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups
Difference in change from baseline period (Month -3 to Day 1) to months 4 to 6 (efficacy evaluation period) in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups.
Baseline period (Month -3 to Day 1) to months 4to 6 (efficacy evaluation period)
Difference in mean dose of intravenous iron (milligram per month) between Auryxia and standard of care treatment groups.
Difference in change from baseline period to efficacy evaluation period in mean dose of intravenous iron (milligrams per month) between Auryxia and standard of care treatment groups.
Baseline period (Month -3 to Day 1) to months 4 to6 (efficacy evaluation period)
Secondary Outcomes (2)
Difference in hemoglobin measurements
Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period).
Difference in serum phosphate measurements
Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period)
Study Arms (2)
Ferric citrate (commercially available, Auryxia)
EXPERIMENTALFerric citrate, (commercially available Auryxia), supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.
Standard of care phosphate lowering therapy
ACTIVE COMPARATORNon-Auryxia phosphate-lowering therapy administered as standard of care.
Interventions
Ferric citrate is an iron-based phosphate binder for the treatment of hyperphosphatemia in subjects with dialysis-dependent chronic kidney disease (DD CKD) and for the treatment of iron deficiency anemia (IDA) in subjects with non-dialysis dependent chronic kidney disease (NDD CKD).
Subjects randomized to SOC will continue their currently prescribed dose of phosphate lowering therapy which will be dosed per local standard of care to achieve community target serum phosphate goals.
Eligibility Criteria
You may qualify if:
- Adult participants greater or equal to 18 years old.
- Diagnosis of end-stage kidney disease and receiving maintenance dialysis (in-center, home hemodialysis or peritoneal dialysis) for greater or equal to 12 weeks prior to randomization.
- Most recent transferrin saturation less than or equal to 50 percent
- Most recent serum phosphate is greater or equal to 3.0 milligrams per deciliter
- Receiving treatment for greater or equal to 8 weeks prior to screening with non-Auryxia phosphate lowering therapy. No requirement for stable dosing within this time frame.
- Receiving treatment for greater or equal to 8 weeks prior to screening with erythropoiesis-stimulating agent (any dose, any type). No requirement for stable dosing within this time frame.
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
You may not qualify if:
- A known allergy or intolerance to Auryxia or any of its constituents.
- Hypersensitivity reaction to previous oral iron therapy.
- History of hemochromatosis or other iron overload syndrome.
- Active malignancy requiring current treatment except for non-melanoma skin cancer regardless of treatment.
- Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal or recreational marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the Investigator).
- Limited life expectancy (less than 6 months), (in the opinion of the Investigator).
- Unable to comply with study requirements or in the opinion of the Investigator not clinically stable to participate in the study.
- Females who are known to be pregnant or are breast-feeding during Screening or are planning to become pregnant and breastfeeding during the study period.
- Evidence of clinically active infection at the time of Screening.
- Use of an investigational medication or participation in an investigational study within 30 days prior to Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- USRC Kidney Researchlead
- Akebia Therapeutics Inc.collaborator
Study Sites (13)
US Renal Care - Dimond
Anchorage, Alaska, 99515, United States
US Renal Care - Mesa
Mesa, Arizona, 85210, United States
US Renal Care - Pine Bluff
Pine Bluff, Arkansas, 71603, United States
US Renal Care - Northridge Roscoe
Granada Hills, California, 91325, United States
US Renal Care - Dalton
Dalton, Georgia, 30720, United States
US Renal Care - Major Health
Shelbyville, Indiana, 46176, United States
US Renal Care - Red Rocks
Gallup, New Mexico, 87301, United States
US Renal Care - North Dallas
Dallas, Texas, 75231, United States
Dallas Renal Group
Dallas, Texas, 75237, United States
US Renal Care - Houston Street
San Antonio, Texas, 78202, United States
US Renal Care - Palo Alto
San Antonio, Texas, 78221, United States
US Renal Care - Pleasanton Rd.
San Antonio, Texas, 78221, United States
US Renal Care - Westover Hills
San Antonio, Texas, 78251, United States
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2021
First Posted
June 10, 2021
Study Start
June 29, 2021
Primary Completion
September 15, 2022
Study Completion
September 15, 2022
Last Updated
November 7, 2022
Record last verified: 2022-11