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Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants (IMPACT)

Primary Purpose

Hyperphosphatemia, Anemia, Iron Deficiency, Renal Insufficiency

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ferric Citrate 1 gram Oral Tablet
Standard of care phosphate-lowering therapy
Sponsored by
USRC Kidney Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • US Renal Care - Dimond
  • US Renal Care - Mesa
  • US Renal Care - Pine Bluff
  • US Renal Care - Northridge Roscoe
  • US Renal Care - Dalton
  • US Renal Care - Major Health
  • US Renal Care - Red Rocks
  • US Renal Care - North Dallas
  • Dallas Renal Group
  • US Renal Care - Houston Street
  • US Renal Care - Palo Alto
  • US Renal Care - Pleasanton Rd.
  • US Renal Care - Westover Hills

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferric citrate (commercially available, Auryxia)

Standard of care phosphate lowering therapy

Arm Description

Ferric 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.

Non-Auryxia phosphate-lowering therapy administered as standard of care.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Difference in hemoglobin measurements
Difference in proportion of measurements with hemoglobin at or above 10.0 grams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period.
Difference in serum phosphate measurements
Difference in proportion of measurements with serum phosphate at or below 5.5 milligrams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period.

Full Information

First Posted
June 8, 2021
Last Updated
November 3, 2022
Sponsor
USRC Kidney Research
Collaborators
Akebia Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04922645
Brief Title
Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants
Acronym
IMPACT
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USRC Kidney Research
Collaborators
Akebia Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Anemia, Iron Deficiency, Renal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric citrate (commercially available, Auryxia)
Arm Type
Experimental
Arm Description
Ferric 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.
Arm Title
Standard of care phosphate lowering therapy
Arm Type
Active Comparator
Arm Description
Non-Auryxia phosphate-lowering therapy administered as standard of care.
Intervention Type
Drug
Intervention Name(s)
Ferric Citrate 1 gram Oral Tablet
Other Intervention Name(s)
Auryxia
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Standard of care phosphate-lowering therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups
Description
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.
Time Frame
Baseline period (Month -3 to Day 1) to months 4to 6 (efficacy evaluation period)
Title
Difference in mean dose of intravenous iron (milligram per month) between Auryxia and standard of care treatment groups.
Description
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.
Time Frame
Baseline period (Month -3 to Day 1) to months 4 to6 (efficacy evaluation period)
Secondary Outcome Measure Information:
Title
Difference in hemoglobin measurements
Description
Difference in proportion of measurements with hemoglobin at or above 10.0 grams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period.
Time Frame
Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period).
Title
Difference in serum phosphate measurements
Description
Difference in proportion of measurements with serum phosphate at or below 5.5 milligrams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period.
Time Frame
Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). 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. 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.
Facility Information:
Facility Name
US Renal Care - Dimond
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99515
Country
United States
Facility Name
US Renal Care - Mesa
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
US Renal Care - Pine Bluff
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
US Renal Care - Northridge Roscoe
City
Granada Hills
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
US Renal Care - Dalton
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30720
Country
United States
Facility Name
US Renal Care - Major Health
City
Shelbyville
State/Province
Indiana
ZIP/Postal Code
46176
Country
United States
Facility Name
US Renal Care - Red Rocks
City
Gallup
State/Province
New Mexico
ZIP/Postal Code
87301
Country
United States
Facility Name
US Renal Care - North Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Dallas Renal Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
US Renal Care - Houston Street
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78202
Country
United States
Facility Name
US Renal Care - Palo Alto
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78221
Country
United States
Facility Name
US Renal Care - Pleasanton Rd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78221
Country
United States
Facility Name
US Renal Care - Westover Hills
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants

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