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

• Sponsor: USRC Kidney Research (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04922645
• Collaborator: Akebia Therapeutics Inc. (Other)
• Enrollment: 200
• Locations: 13
• Arms: 2
• Anticipated Duration (Months): 10.1
• Patients Per Site: 15.4
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperphosphatemia; Anemia, Iron Deficiency; Renal Insufficiency	Drug: Ferric Citrate 1 gram Oral Tablet; Drug: Standard of care phosphate-lowering therapy	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 29, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ferric citrate (commercially available, Auryxia) 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.	Drug: Ferric Citrate 1 gram Oral Tablet; 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).; Other Names: Auryxia
Active Comparator: Standard of care phosphate lowering therapy Non-Auryxia phosphate-lowering therapy administered as standard of care.	Drug: Standard of care phosphate-lowering therapy; 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.

Outcome Measures

Primary Outcome Measures

1. Difference 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 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.

2. Difference in mean dose of intravenous iron (milligram per month) between Auryxia and standard of care treatment groups. [Baseline period (Month -3 to Day 1) to months 4 to6 (efficacy evaluation period)]

   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

1. Difference in hemoglobin measurements [Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period).]

   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.

2. Difference in serum phosphate measurements [Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	US Renal Care - Dimond	Anchorage	Alaska	United States	99515
2	US Renal Care - Mesa	Mesa	Arizona	United States	85210
3	US Renal Care - Pine Bluff	Pine Bluff	Arkansas	United States	71603
4	US Renal Care - Northridge Roscoe	Granada Hills	California	United States	91325
5	US Renal Care - Dalton	Dalton	Georgia	United States	30720
6	US Renal Care - Major Health	Shelbyville	Indiana	United States	46176
7	US Renal Care - Red Rocks	Gallup	New Mexico	United States	87301
8	US Renal Care - North Dallas	Dallas	Texas	United States	75231
9	Dallas Renal Group	Dallas	Texas	United States	75237
10	US Renal Care - Houston Street	San Antonio	Texas	United States	78202
11	US Renal Care - Palo Alto	San Antonio	Texas	United States	78221
12	US Renal Care - Pleasanton Rd.	San Antonio	Texas	United States	78221
13	US Renal Care - Westover Hills	San Antonio	Texas	United States	78251

Sponsors and Collaborators

• USRC Kidney Research
• Akebia Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: USRC Kidney Research
• ClinicalTrials.gov Identifier: NCT04922645
• Other Study ID Numbers: USRC-2021-001
• First Posted: Jun 10, 2021
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• 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
• Additional relevant MeSH terms: Renal Insufficiency; Anemia; Anemia, Iron-Deficiency; Hyperphosphatemia

Study Results

No Results Posted as of Apr 1, 2022