What is the mechanism of action of this treatment?

Phosphate binders, such as ferric citrate, are commonly used to manage high phosphate levels, particularly in patients with chronic kidney disease. These agents work by binding to dietary phosphate in the gastrointestinal tract, forming insoluble complexes that are excreted in the feces, thereby reducing phosphate absorption into the bloodstream. This is crucial for patients with high phosphate levels because elevated phosphate can lead to vascular calcification, bone disease, and cardiovascular complications. Ferric citrate also provides the added benefit of being an iron source, which can help address anemia commonly seen in these patients.

What side effects are associated with this type of intervention?

Common treatments for high phosphate levels, such as ferric citrate, can have several side effects. These may include gastrointestinal issues like diarrhea, constipation, nausea, and abdominal pain. As an iron source, ferric citrate can also lead to iron overload, which may cause symptoms like joint pain, fatigue, and liver damage. Additionally, there is a risk of darkened stools due to the iron content. Patients should be monitored for these side effects and managed accordingly.

What prior FDA approvals exist?

The FDA has approved several phosphate binders for the treatment of high phosphate levels in patients with chronic kidney disease. These include sevelamer (Renvela, Renagel), lanthanum carbonate (Fosrenol), and calcium acetate (PhosLo). Ferric citrate (Auryxia) is another FDA-approved phosphate binder that also serves as an iron source, making it beneficial for patients with iron deficiency. These treatments help manage hyperphosphatemia by binding dietary phosphate in the gastrointestinal tract, thereby reducing its absorption.

What other types of research exist?

Promising novel alternatives to Ferric Citrate for managing high phosphate levels include Sucroferric Oxyhydroxide and Ferric Maltol. Sucroferric Oxyhydroxide is a phosphate binder that has shown efficacy in reducing serum phosphate levels with a lower pill burden. Ferric Maltol is an iron replacement therapy that also helps manage iron deficiency in patients with chronic kidney disease. Both alternatives offer potential benefits in terms of efficacy and patient compliance.

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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

Must not have

Evidence of a clinically active infection requiring antibiotics at Randomization

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

Pivotal Trial

Summary

This trial tests an iron supplement in patients with severe kidney disease who are not yet on dialysis. The aim is to see if it can delay dialysis or reduce death risk. Participants will take the supplement with meals and be monitored over several months. The supplement has been shown to effectively manage certain health markers in patients with 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking antibiotics for an active infection.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I am scheduled to receive a kidney transplant from a living donor.

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I have a history of conditions causing too much iron in my blood.

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I am currently being treated for cancer, except for non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality

Secondary study objectives

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)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ferric Citrate 1 GM Oral Tablet [AURYXIA]

2022

Completed Phase 3

~290

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Phosphate binders, such as ferric citrate, are commonly used to manage high phosphate levels, particularly in patients with chronic kidney disease. These agents work by binding to dietary phosphate in the gastrointestinal tract, forming insoluble complexes that are excreted in the feces, thereby reducing phosphate absorption into the bloodstream. This is crucial for patients with high phosphate levels because elevated phosphate can lead to vascular calcification, bone disease, and cardiovascular complications. Ferric citrate also provides the added benefit of being an iron source, which can help address anemia commonly seen in these patients.