HyperphosphatemiaPhase 4IMPACTNCT04922645
Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants
A Phase 4 study testing Ferric Citrate 1 gram Oral Tablet in people with Hyperphosphatemia and Anemia, Iron Deficiency, run by USRC Kidney Research at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia, Anemia, Iron Deficiency, Renal Insufficiency
- What is being tested?
- Ferric Citrate 1 gram Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 13 sitesUnited States
- Study dates
- 29 Jun 2021to 15 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
US Renal Care - Dimond
Anchorage, Alaska, 99515
US Renal Care - North Dallas
Dallas, Texas, 75231
Dallas Renal Group
Dallas, Texas, 75237
US Renal Care - Dalton
Dalton, Georgia, 30720
US Renal Care - Red Rocks
Gallup, New Mexico, 87301
US Renal Care - Northridge Roscoe
Granada Hills, California, 91325
US Renal Care - Mesa
Mesa, Arizona, 85210
US Renal Care - Pine Bluff
Pine Bluff, Arkansas, 71603
US Renal Care - Houston Street
San Antonio, Texas, 78202
US Renal Care - Palo Alto
San Antonio, Texas, 78221
US Renal Care - Pleasanton Rd.
San Antonio, Texas, 78221
US Renal Care - Westover Hills
San Antonio, Texas, 78251
US Renal Care - Major Health
Shelbyville, Indiana, 46176
About this study
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
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.
Read the 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.
- Being tested
- Ferric Citrate 1 gram Oral Tablet, Standard of care phosphate-lowering therapy
- Medical subject headings
- Hyperphosphatemia, Anemia, Iron-Deficiency, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Citrate 1 gram Oral TabletDrug
Also called Auryxia
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).
Standard of care phosphate-lowering therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ferric citrate (commercially available, Auryxia) | Experimental | 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. Receives: Drug: Ferric Citrate 1 gram Oral Tablet |
| Standard of care phosphate lowering therapy | Active comparator | Non-Auryxia phosphate-lowering therapy administered as standard of care. Receives: Drug: Standard of care phosphate-lowering therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline period (Month -3 to Day 1) to months 4 to6 (efficacy evaluation period)
Secondary outcomes (2)
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.
Measured: Baseline period (Month -3 to Day 1) to months 4to6 (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.
Measured: Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start29 Jun 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- USRC Kidney Research
- Sponsor type
- Research network
- Collaborators
- Akebia Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922645
- Sponsor's protocol ID
- USRC-2021-001
- Acronym
- IMPACT
- Status last verified
- Nov 2022
- First submitted
- 8 Jun 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40576086Block GA, Mizani MR, Broumand V, Newby FD, Erinle A, Arias C, Block M, Brillhart S, Leppink A, Danese M, Dittrich M. A Randomized Trial of the Impact of Ferric Citrate on Erythropoietin and Intravenous Iron Use in Patients Receiving Dialysis. Am J Nephrol. 2024;55(5):520-528. doi: 10.1159/000540227. Epub 2024 Jul 15.
PubMed 38972306
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04922645
- Acronym / sponsor ID
- IMPACT / USRC-2021-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- USRC Kidney ResearchResearch network
- Collaborators
- Akebia Therapeutics
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric citrate (commercially available, Auryxia) | Experimental | Drug: Ferric Citrate 1 gram Oral TabletFerric 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 comparator | Drug: Standard of care phosphate-lowering therapyNon-Auryxia phosphate-lowering therapy administered as standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Citrate 1 gram Oral TabletAlso: AuryxiaFerric 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). | Drug | Ferric citrate (commercially available, Auryxia) |
| Standard of care phosphate-lowering therapySubjects 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. | Drug | Standard of care phosphate lowering therapy |
Primary outcome
Difference 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)
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.
Time frame: 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.
2 secondary outcomes
Difference in hemoglobin measurements
Time frame: Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period).
Difference in serum phosphate measurements
Time frame: Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Derived from this study: PubMed 40576086Natale 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.
- Derived from this study: PubMed 38972306Block GA, Mizani MR, Broumand V, Newby FD, Erinle A, Arias C, Block M, Brillhart S, Leppink A, Danese M, Dittrich M. A Randomized Trial of the Impact of Ferric Citrate on Erythropoietin and Intravenous Iron Use in Patients Receiving Dialysis. Am J Nephrol. 2024;55(5):520-528. doi: 10.1159/000540227. Epub 2024 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Citrate 1 gram Oral Tablet in people with Hyperphosphatemia and Anemia, Iron Deficiency, run by USRC Kidney Research at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922645, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.