Anemia, Iron DeficiencyPhase 3FRONTIERNCT05085275
Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease
A Phase 3 study testing Ferric Citrate 1 GM Oral Tablet [AURYXIA] in people with Anemia, Iron Deficiency and Hyperphosphatemia, run by USRC Kidney Research at 23 sites in United States.
Trial summary
A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron Deficiency, Hyperphosphatemia, Renal Insufficiency, Chronic
- What is being tested?
- Ferric Citrate 1 GM Oral Tablet [AURYXIA]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 23 sitesUnited States
- Study dates
- 30 Mar 2022to 24 Jan 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 patients greater or equal to 18 years old.
- Diagnosis of NDD advanced CKD, regardless of etiology. Advanced CKD is defined as at least one local laboratory determined estimated glomerular filtration rate (eGFR) ≤20 ml/min/1.73m2 (calculated per any commonly used method or equation for estimating eGFR) within 90 days of Day 1.
- Most recent transferrin saturation (TSAT) less than or equal to 45% within 45 days of Day 1.
- Most recent serum phosphate is greater or equal to 3.0 mg per dL within 45 days of Day 1.
- Most recent ferritin is less than or equal to 500 ng per mL within 45 days of Day 1.
- Women of child-bearing potential must have a negative serum or urine pregnancy test within 28 days prior to Day 1.
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Who cannot join
- Patients who, in the opinion of the Investigator, have acute kidney injury rather than CKD.
- Patients with planned/imminent maintenance dialysis, or that are anticipated to begin maintenance dialysis within 8 weeks from Screening, in the opinion of the Investigator.
- A known allergy or intolerance to ferric citrate or any of its constituents.
- Hypersensitivity reaction to previous oral iron therapy.
- History of hemochromatosis or iron overload syndrome (e.g., hereditary sideroblastic anemia, thalassemia, polycythemia vera).
- Active malignancy requiring current treatment except for non-melanoma skin cancer regardless of treatment.
Show all 13Show fewer
- Active drug or alcohol dependence or abuse (excluding tobacco use or use of medical 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.
- 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 a clinically active infection requiring antibiotics at Randomization.
- Unable to comply with study requirements or in the opinion of the Investigator, not clinically stable to participate in the study.
- Use of an investigational medication or participation in an investigational study within 30 days prior to Day 1.
- Patients with a scheduled date for receipt of living donor kidney transplant
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Dialysis Clinic, Inc.
Albany, Georgia, 31701
Nephrology Associates of Western NY
Amherst, New York, 14228
Balboa Research SMO
Chula Vista, California, 91910
Nephrology and Hypertension Specialists, PC
Dalton, Georgia, 30720
Balboa Research SMO
El Centro, California, 92243
Balboa Research SMO
Escondido, California, 92025
Associates in Nephrology
Fort Myers, Florida, 33908
High Desert Nephrology Associates
Gallup, New Mexico, 87301
Kidney Associates of Kansas City
Kansas City, Missouri, 64131
Dialysis Clinic, Inc.
Knoxville, Tennessee, 37920
Balboa Research SMO
La Mesa, California, 91942
South Texas Renal Care Group
Live Oak, Texas, 78233
Rocky Mountain Kidney Care
Lone Tree, Colorado, 80124
Arkansas Nephrology & Hypertension Clinic
Pine Bluff, Arkansas, 71603
South Texas Renal Care Group
San Antonio, Texas, 78202
South Texas Renal Care Group
San Antonio, Texas, 78211
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212
South Texas Renal Care Group
San Antonio, Texas, 78221
South Texas Renal Care Group
San Antonio, Texas, 78251
Balboa Research SMO - Kearney Mesa
San Diego, California, 92111
Major Health Partners
Shelbyville, Indiana, 46176
Nephrology-Hypertension Associates of Central NJ
South River, New Jersey, 08882
Spartanburg Nephrology Associates
Spartanburg, South Carolina, 29302
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Effect of Ferric Citrate on Time to a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality vs Placebo in Adults With Advanced CKD
A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality.
Read the detailed description
This multicenter, randomized, double-blind, placebo-controlled clinical trial is being conducted to determine the effect of ferric citrate on the time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality in patients with non-dialysis dependent, advanced CKD. Up to 400 subjects will be randomized in 1:1 ratio to receive either ferric citrate or matching placebo. All subjects will initiate dosing at 2 tablets per meal or snacks, up to 3 times per day (maximum of 6 tablets per day). The dose of ferric citrate/placebo will only be adjusted based on safety and/or tolerability. Given the double-blind design of this trial, investigators will be instructed to not prescribe commercial Auryxia to either study arm. Study visits during the treatment period are to be conducted as part of routine scheduled clinical encounters. Standard of care local laboratory results will be collected however no study specific laboratory tests other than a pregnancy test in women of child-bearing potential will be required.
- Conditions
- Anemia, Iron Deficiency, Hyperphosphatemia, Renal Insufficiency, Chronic, Renal Anemia, Disease Progression, Cardiovascular
- Being tested
- Ferric Citrate 1 GM Oral Tablet [AURYXIA], Placebo
- Keywords
- ferric citrate
- Medical subject headings
- Anemia, Iron-Deficiency, Hyperphosphatemia, Renal Insufficiency, Chronic, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Citrate 1 GM Oral Tablet [AURYXIA]Drug
Also called Auryxia
All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed.
PlaceboDrug
All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed.
| Study group | Role | What they receive |
|---|---|---|
| Ferric citrate | Experimental | 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 GM Oral Tablet [AURYXIA] |
| Placebo | Placebo comparator | Tablets, matching in color and size to ferric citrate. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality
Number of participants achieving a composite endpoint of initiation of maintenance dialysis or all-cause mortality
Measured: 9 months
Secondary outcomes (3)
Hospitalization Events Reported as a Serious Adverse Event (SAE) (Excluding Disease-related Hospitalization [e.g., Dialysis Access Placement, Dialysis Initiation, Kidney Transplant] and Elective Procedures)
Number of hospitalization events reported as a serious adverse event (SAE) (excluding disease-related hospitalization [e.g., dialysis access placement, dialysis initiation, kidney transplant] and elective procedures)
Measured: 9 months
Component of Primary - Initiation of Maintenance Dialysis
Component of Primary - Number of participants initiating maintenance dialysis
Measured: 9 months
Component of Primary - All-Cause Mortality
Component of Primary - Number of patients reaching endpoint of all-cause mortality.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start30 Mar 2022
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anemia, Iron DeficiencyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo controlled, double-blind, parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- USRC Kidney Research
- Sponsor type
- Research network
- Collaborators
- Akebia Therapeutics
- Responsible party
- Sponsor
- Investigators
- Geoff Block, MD, Principal investigator, USRC Kidney Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085275
- Sponsor's protocol ID
- USRC-2021-002
- Acronym
- FRONTIER
- Status last verified
- Apr 2025
- First submitted
- 6 Oct 2021
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Effect of Ferric Citrate on Time to a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality vs Placebo in Adults With Advanced CKD
- ClinicalTrials.gov ID
- NCT05085275
- Acronym / sponsor ID
- FRONTIER / USRC-2021-002
- Conditions
- Anemia, Iron Deficiency, Hyperphosphatemia, Renal Insufficiency, Chronic, Renal Anemia, Disease Progression, Cardiovascular
- Keywords
- ferric citrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- USRC Kidney ResearchResearch network
- Collaborators
- Akebia Therapeutics
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Posted 29 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality.
Detailed description
This multicenter, randomized, double-blind, placebo-controlled clinical trial is being conducted to determine the effect of ferric citrate on the time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality in patients with non-dialysis dependent, advanced CKD. Up to 400 subjects will be randomized in 1:1 ratio to receive either ferric citrate or matching placebo. All subjects will initiate dosing at 2 tablets per meal or snacks, up to 3 times per day (maximum of 6 tablets per day). The dose of ferric citrate/placebo will only be adjusted based on safety and/or tolerability. Given the double-blind design of this trial, investigators will be instructed to not prescribe commercial Auryxia to either study arm. Study visits during the treatment period are to be conducted as part of routine scheduled clinical encounters. Standard of care local laboratory results will be collected however no study specific laboratory tests other than a pregnancy test in women of child-bearing potential will be required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo controlled, double-blind, parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Ferric citrate | Experimental | Drug: Ferric Citrate 1 GM Oral Tablet [AURYXIA]Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks. |
| Placebo | Placebo comparator | Drug: PlaceboTablets, matching in color and size to ferric citrate. |
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 patients greater or equal to 18 years old.
- Diagnosis of NDD advanced CKD, regardless of etiology. Advanced CKD is defined as at least one local laboratory determined estimated glomerular filtration rate (eGFR) ≤20 ml/min/1.73m2 (calculated per any commonly used method or equation for estimating eGFR) within 90 days of Day 1.
- Most recent transferrin saturation (TSAT) less than or equal to 45% within 45 days of Day 1.
- Most recent serum phosphate is greater or equal to 3.0 mg per dL within 45 days of Day 1.
- Most recent ferritin is less than or equal to 500 ng per mL within 45 days of Day 1.
Key exclusion criteria (13 listed)
- Patients who, in the opinion of the Investigator, have acute kidney injury rather than CKD.
- Patients with planned/imminent maintenance dialysis, or that are anticipated to begin maintenance dialysis within 8 weeks from Screening, in the opinion of the Investigator.
- A known allergy or intolerance to ferric citrate or any of its constituents.
- Hypersensitivity reaction to previous oral iron therapy.
- History of hemochromatosis or iron overload syndrome (e.g., hereditary sideroblastic anemia, thalassemia, polycythemia vera).
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 GM Oral Tablet [AURYXIA]Also: AuryxiaAll subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed. | Drug | Ferric citrate |
| PlaceboAll subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed. | Drug | Placebo |
Primary outcome
Number of Participants Achieving a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality
Time frame: 9 months
Number of participants achieving a composite endpoint of initiation of maintenance dialysis or all-cause mortality
3 secondary outcomes
Hospitalization Events Reported as a Serious Adverse Event (SAE) (Excluding Disease-related Hospitalization [e.g., Dialysis Access Placement, Dialysis Initiation, Kidney Transplant] and Elective Procedures)
Time frame: 9 months
Component of Primary - Initiation of Maintenance Dialysis
Time frame: 9 months
Component of Primary - All-Cause Mortality
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Geoff Block, MD principal investigator
USRC Kidney Research
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric Citrate 1 GM Oral Tablet [AURYXIA] in people with Anemia, Iron Deficiency and Hyperphosphatemia, run by USRC Kidney Research at 23 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 13 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 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Achieving a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025.