Clinical trial NCT04922645: Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperphosphatemia
Anemia, Iron Deficiency
Renal Insufficiency
Lead sponsor: USRC Kidney Research
Sponsor class: NETWORK
Collaborators: name: Akebia Therapeutics Inc.
First posted: 2021-06-10
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 1:1 (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.

Eligibility criteria: Inclusion Criteria:

1. Adult participants greater or equal to 18 years old.
2. 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.
3. Most recent transferrin saturation less than or equal to 50 percent
4. Most recent serum phosphate is greater or equal to 3.0 milligrams per deciliter
5. 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.
6. 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.
7. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion Criteria:

1. A known allergy or intolerance to Auryxia or any of its constituents.
2. Hypersensitivity reaction to previous oral iron therapy.
3. History of hemochromatosis or other iron overload syndrome.
4. Active malignancy requiring current treatment except for non-melanoma skin cancer regardless of treatment.
5. 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).
6. Limited life expectancy (less than 6 months), (in the opinion of the Investigator).
7. Scheduled organ transplant and participants on the kidney transplant wait-list who are expected to receive a transplant within 6 months of screening. Being active on transplant list is not an exclusion. Previous kidney transplant is not an exclusion.
8. Unable to comply with study requirements or in the opinion of the Investigator not clinically stable to participate in the study.
9. 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.
10. Evidence of clinically active infection at the time of Screening.
11. Use of an investigational medication or participation in an investigational study within 30 days prior to Screening.

Primary outcomes:
measure: Difference in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups
timeFrame: Baseline period (Month -3 to Day 1) to months 4to 6 (efficacy evaluation period)
measure: Difference in mean dose of intravenous iron (milligram per month) between Auryxia and standard of care treatment groups.
timeFrame: Baseline period (Month -3 to Day 1) to months 4 to6 (efficacy evaluation period)
Secondary outcomes:
measure: Difference in hemoglobin measurements
timeFrame: Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period).
measure: Difference in serum phosphate measurements
timeFrame: Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period)
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: US Renal Care - Dimond
state: Alaska
city: Mesa
country: United States
facility: US Renal Care - Mesa
state: Arizona
city: Pine Bluff
country: United States
facility: US Renal Care - Pine Bluff
state: Arkansas
city: Granada Hills
country: United States
facility: US Renal Care - Northridge Roscoe
state: California
city: Dalton
country: United States
facility: US Renal Care - Dalton
state: Georgia
city: Shelbyville
country: United States
facility: US Renal Care - Major Health
state: Indiana
city: Gallup
country: United States
facility: US Renal Care - Red Rocks
state: New Mexico
city: Dallas
country: United States
facility: US Renal Care - North Dallas
state: Texas
city: Dallas
country: United States
facility: Dallas Renal Group
state: Texas
city: San Antonio
country: United States
facility: US Renal Care - Houston Street
state: Texas
city: San Antonio
country: United States
facility: US Renal Care - Palo Alto
state: Texas
city: San Antonio
country: United States
facility: US Renal Care - Pleasanton Rd.
state: Texas
city: San Antonio
country: United States
facility: US Renal Care - Westover Hills
state: Texas
Study officials:
References: