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Iron-Based Phosphate Binder

Ferric Citrate for Chronic Kidney Disease (FRONTIER Trial)

Phase 3
Waitlist Available
Led By Geoff Block, MD
Research Sponsored by USRC Kidney Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 within 90 days of Day 1
Adult patients greater or equal to 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

FRONTIER Trial Summary

This trial found that ferric citrate may improve outcomes for people with advanced chronic kidney disease.

Who is the study for?
Adults over 18 with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2), high phosphate levels, and iron deficiency can join this trial. They must not be pregnant or planning pregnancy, have a life expectancy of more than 6 months, and no recent drug abuse or hypersensitivity to oral iron therapy.Check my eligibility
What is being tested?
The study tests if ferric citrate tablets can prevent renal failure better than a placebo in adults with severe chronic kidney disease. It's a randomized, double-blind trial lasting for 9 months to see if it delays the need for dialysis or impacts mortality.See study design
What are the potential side effects?
Potential side effects may include digestive issues like constipation or diarrhea due to the iron content in ferric citrate. There might also be risks of iron overload which could affect various organs.

FRONTIER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney function is severely reduced, with an eGFR of 20 ml/min/1.73m2 or less.
Select...
I am 18 years old or older.

FRONTIER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality
Secondary outcome measures
Component of Primary - Time to All-Cause Mortality
Component of Primary - Time to Initiation of Maintenance Dialysis
Time to first hospitalization event reported as a serious adverse event (SAE) (excluding disease-related hospitalization [e.g., dialysis access placement, dialysis initiation, kidney transplant] and elective procedures)

FRONTIER Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ferric citrateExperimental Treatment1 Intervention
Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.
Group II: PlaceboPlacebo Group1 Intervention
Tablets, matching in color and size to ferric citrate.

Find a Location

Who is running the clinical trial?

USRC Kidney ResearchLead Sponsor
2 Previous Clinical Trials
375 Total Patients Enrolled
Akebia TherapeuticsIndustry Sponsor
33 Previous Clinical Trials
9,959 Total Patients Enrolled
Geoff Block, MDPrincipal InvestigatorUSRC Kidney Research
2 Previous Clinical Trials
2,542 Total Patients Enrolled

Media Library

Ferric Citrate (Iron-Based Phosphate Binder) Clinical Trial Eligibility Overview. Trial Name: NCT05085275 — Phase 3
High Phosphate Levels Research Study Groups: Ferric citrate, Placebo
High Phosphate Levels Clinical Trial 2023: Ferric Citrate Highlights & Side Effects. Trial Name: NCT05085275 — Phase 3
Ferric Citrate (Iron-Based Phosphate Binder) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05085275 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different parts of the country is this trial being conducted?

"In total, there are 23 enrolment sites for this trial. These locations include Balboa Research SMO in La Mesa, California; Balboa Research SMO - Kearney Mesa in San Diego, New york; Nephrology Associates of Western NY in Amherst, Colorado; and 20 others."

Answered by AI

Has this research been conducted before?

"At the moment, there are 5 ongoing clinical trials for Ferric Citrate 1 GM Oral Tablet [AURYXIA]. These international studies began in 2020 and have so-far been conducted across 29 cities in 3 countries. The first of these trials was completed as a Phase 3 drug approval stage sponsored by Panion & BF Biotech Inc.. In total, 200 participants were involved. Since 2020, a total of 18304 trials have been completed worldwide."

Answered by AI

How many individuals are enrolled in this clinical trial presently?

"Yes, the information on clinicaltrials.gov indicates that this trial is presently looking for patients. The clinical trial was originally posted on 3/30/2022 and was most recently updated on 8/15/2022. The trial is looking for 400 participants at 20 locations."

Answered by AI

What is the primary medical condition that Ferric Citrate 1 GM Oral Tablet [AURYXIA] has been known to improve?

"Ferric Citrate 1 GM Oral Tablet [AURYXIA] is a medication prescribed to patients with hyperphosphataemia. It can also help those not on dialysis, chronic kidney disease (ckd), anddialysis therapy."

Answered by AI

Does the data on Ferric Citrate 1 GM Oral Tablet [AURYXIA] stand alone, or is it corroborated by other similar research?

"The first trials for Ferric Citrate 1 GM Oral Tablet [AURYXIA] were completed in 2020 at the Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital. Out of the 18304 total trials conducted, 5 are still active. The majority of these ongoing studies are taking place in La Mesa, California."

Answered by AI

Are we currently enrolling new participants for this research?

"Yes, that is accurate. The clinical trial in question is still looking for patients, with 400 needed in total. 20 different locations are being used to find participants. The study was posted on March 30th, 2022 and updated on August 15th of the same year."

Answered by AI

What sort of health risks does Ferric Citrate 1 GM Oral Tablet [AURYXIA] present?

"There is some evidence that Ferric Citrate 1 GM Oral Tablet [AURYXIA] is effective, and it has been through multiple rounds of testing for safety, so we give it a 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
South Texas Renal Care Group

Why did patients apply to this trial?

interested in helping science help kidney disease sufferers.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease
2022. "Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05085275.
All > Chronic Kidney Disease
~43 spots leftby Aug 2024
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