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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
Adult patients greater or equal to 18 years old
Be older than 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 belowSelect...
I am 18 years old or older.
FRONTIER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking antibiotics for an active infection.I am expected to start regular dialysis soon, within the next 8 weeks.My doctor thinks my kidney issues are due to a sudden injury, not chronic disease.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.Women who could become pregnant must have a negative pregnancy test within 28 days before starting the study.I am scheduled to receive a kidney transplant from a living donor.My kidney function is severely reduced, with an eGFR of 20 ml/min/1.73m2 or less.I am 18 years old or older.You had a bad reaction to iron pills in the past.I have a history of conditions causing too much iron in my blood.You are allergic to ferric citrate or any of its ingredients.Your recent transferrin saturation (TSAT) level is 45% or less within 45 days before the start of the study.Your ferritin blood level is 500 ng/mL or less within 45 days before the start of the trial.I am currently being treated for cancer, except for non-melanoma skin cancer.Your blood phosphate level is higher than 3.0 mg per dL within 45 days before the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Ferric citrate
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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