Ferric Citrate for Chronic Kidney Disease

Not currently recruiting at 13 trial locations

Overseen By Akebia Medical Information

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Keryx Biopharmaceuticals

Disqualifiers: Active GI disorder, Liver transaminases, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ferric citrate, a treatment designed to help children with chronic kidney disease (CKD) who have high phosphate levels in their blood. The main goal is to assess the safety and tolerability of the treatment for children requiring dialysis or with significantly reduced kidney function. Children with CKD-related high phosphate levels for at least three months, who are either undergoing dialysis or have low kidney function without dialysis, might be suitable candidates. As a Phase 3 trial, this represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment for CKD.

Will I have to stop taking my current medications?

If you are currently taking phosphate binders and your serum phosphorus levels are not above the specified limits, you will need to stop taking them for about 1 to 4 weeks before starting the trial.

Is there any evidence suggesting that ferric citrate is likely to be safe for humans?

Research has shown that ferric citrate is generally safe for people with chronic kidney disease (CKD). It helps manage high phosphate levels in the blood and can also improve iron levels.

Studies have found that ferric citrate may cause some stomach-related side effects, such as upset or discomfort, which are usually mild to moderate.

Ferric citrate is already approved for adults with CKD, indicating its general safety. However, this study aims to further evaluate its safety and tolerance in children and teenagers with CKD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ferric citrate is unique because it not only helps manage iron levels but also reduces phosphate levels in people with chronic kidney disease. Most standard treatments for this condition focus solely on controlling phosphate with medications like phosphate binders. Ferric citrate, however, adds the benefit of addressing iron deficiency, a common issue in these patients, by providing an additional source of iron. Researchers are excited because this dual action can potentially simplify treatment regimens and improve overall patient outcomes.

What evidence suggests that ferric citrate might be an effective treatment for hyperphosphatemia in chronic kidney disease?

Research has shown that ferric citrate, the treatment under study in this trial, effectively treats high phosphate levels in patients with chronic kidney disease (CKD). Studies have found that ferric citrate can significantly reduce phosphate absorption, with one study reporting nearly a 40% drop in phosphate levels in urine. This treatment also improves iron levels, a common concern for CKD patients. Additionally, ferric citrate acts as a dietary phosphorus binder, crucial for managing mineral imbalances in CKD. These findings support the potential effectiveness of ferric citrate in managing high phosphate levels in children with CKD. ^{4 6 7 8 9}

Who Is on the Research Team?

Chief Medical Officer

Principal Investigator

Akebia Therapeutics Inc.

Are You a Good Fit for This Trial?

This trial is for children with chronic kidney disease (CKD) who have high phosphate levels. They must have been on dialysis or have an eGFR <30 mL/min/1.73 m^2, weigh at least 40 kg, and not be pregnant. Participants need a history of CKD-related hyperphosphatemia for 3+ months and agree to birth control if applicable.

Inclusion Criteria

Your hemodialysis treatment has been effective enough with a certain level reached during at least one session in the past 2 months.

Your blood ferritin level is less than 500 ng/mL.

I have had high phosphate levels due to kidney disease for at least 3 months.

Exclusion Criteria

Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the Investigator)

Any other medical condition that, in the opinion of the Investigator, renders the participant unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the participant

I cannot swallow pills and do not use a feeding tube for medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ferric citrate for 36 weeks at a starting dose based on body weight categories

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ferric Citrate

Trial Overview The study tests the safety and tolerability of ferric citrate in pediatric patients with hyperphosphatemia due to CKD. It aims to see how well these young patients handle the medication over time.

How Is the Trial Designed?

Group I: Ferric citrate Experimental Treatment 1 Intervention

Participants aged 6 to \< 17 years will receive ferric citrate for 36 weeks at a starting dose based on body weight categories.

Ferric Citrate is already approved in United States for the following indications:

Approved in United States as Auryxia for:

• Hyperphosphatemia in patients with chronic kidney disease on dialysis
• Iron-deficiency anemia in patients with chronic kidney disease not on dialysis

Who Is Running the Clinical Trial?

Keryx Biopharmaceuticals

Lead Sponsor

Trials

21

Recruited

4,200+

Published Research Related to This Trial

Auryxia® (ferric citrate) is effective in managing chronic kidney disease (CKD) by lowering serum phosphate levels and improving iron deficiency anemia, making it a dual-purpose treatment for CKD patients.

Clinical studies have shown that Auryxia significantly reduces levels of fibroblast growth factor 23 (FGF23), a key risk factor for cardiovascular issues in CKD, although further long-term studies are needed to assess its cardiovascular effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action and Clinical Attributes of Auryxia&#174; (Ferric Citrate). Ganz, T., Bino, A., Salusky, IB.[2021]

In a study involving 378 patients with chronic kidney disease (CKD) and iron-deficiency anemia (IDA), ferric citrate treatment showed similar effectiveness in increasing hemoglobin levels for patients with and without heart failure (HF), with 43% of HF patients responding positively to treatment.

While ferric citrate was generally safe, adverse events related to HF were more common in patients with HF, suggesting that while it can be used for IDA in CKD patients, careful monitoring is needed for those with concurrent heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of Oral Ferric Citrate in Patients With Iron-Deficiency Anemia and Chronic Kidney Disease With or Without Heart Failure. McCullough, PA., Uhlig, K., Neylan, JF., et al.[2019]

Ferric citrate is a new phosphate-binding agent that works by releasing ferric ions in the bowel to bind dietary phosphorus, which is then excreted, showing promise in treating patients with end-stage renal disease.

Current studies indicate that ferric citrate is effective and safe, with only mild gastrointestinal side effects, and an ongoing Phase III trial is further evaluating its safety and efficacy in dialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferric citrate: a novel phosphate-binding agent. Umanath, K., Niecestro, R., Lewis, JB., et al.[2019]

Ferric citrate (Zerenex™) has been confirmed as effective and safe in controlling serum phosphorus levels in patients with end-stage renal disease during Phase III trials.

In addition to managing hyperphosphatemia, ferric citrate improves iron levels and reduces the need for intravenous iron and erythropoietin, which may help in treating anemia related to end-stage renal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferric citrate spans mineral metabolism and anemia domains in ESRD: a review of efficacy and safety data. Sinsakul, M., Rodby, R., Umanath, K., et al.[2015]

Ferric citrate (Auryxia) is effective in treating hyperphosphatemia, a condition characterized by elevated phosphate levels in the blood, particularly in patients with chronic kidney disease.

The treatment works by binding phosphate in the gastrointestinal tract, reducing its absorption and helping to lower phosphate levels safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferric citrate (auryxia) for the treatment of hyperphosphatemia. Pennoyer, A., Bridgeman, MB.[2020]

In a phase 3 study involving 90 nondialysis-dependent CKD patients, ferric citrate hydrate significantly reduced serum phosphate levels by an average of 1.29 mg/dl compared to a negligible change in the placebo group, demonstrating its efficacy as a phosphate binder.

Ferric citrate hydrate not only helped achieve target serum phosphate levels in 64.9% of patients but also lowered fibroblast growth factor-23 levels and increased serum iron parameters, indicating a beneficial effect on mineral metabolism in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferric citrate hydrate for the treatment of hyperphosphatemia in nondialysis-dependent CKD. Yokoyama, K., Hirakata, H., Akiba, T., et al.[2022]

Ferric citrate hydrate (JTT-751) effectively reduces phosphorus absorption in normal rats and increases fecal phosphorus excretion, indicating its potential as a treatment for hyperphosphatemia.

In chronic renal failure rats, JTT-751 significantly lowered serum phosphorus levels and prevented complications such as ectopic calcification, secondary hyperparathyroidism, and bone abnormalities, suggesting its efficacy in managing kidney disease-related phosphorus issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferric citrate hydrate, a new phosphate binder, prevents the complications of secondary hyperparathyroidism and vascular calcification. Iida, A., Kemmochi, Y., Kakimoto, K., et al.[2015]

Citations

1. auryxiahcp.com auryxiahcp.com/iron-deficiency-anemia/efficacy/

Efficacy | AURYXIA® (ferric citrate) tablets For HCPs This trial evaluated the efficacy and safety of AURYXIA for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4422633/

Ferric Citrate (Auryxia) for the Treatment of ... The authors concluded that ferric citrate is effective as a dietary phosphorus binder and improves ferritin and TSAT levels and reduces IV iron and ESA ...

3. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1285012/full

Ferric citrate for the treatment of hyperphosphatemia and ... The application of ferric citrate therapy has yielded unexpected benefits in recent years for CKD patients suffering from hyperphosphatemia ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05085275

NCT05085275 | Ferric Citrate for the Prevention of Renal ... A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced ...

5. ajkd.org ajkd.org/article/S0272-6386(14)01357-2/fulltext

A 12-Week, Double-Blind, Placebo-Controlled Trial of ... Our finding that ferric citrate reduced urinary phosphate levels by nearly 40% demonstrates its biological effect to reduce phosphate absorption. Many, though ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9203387/

Safety and effectiveness of ferric citrate hydrate in serum ... Ferric citrate hydrate (FC) is an oral iron-based phosphate binder that is used to treat hyperphosphatemia in patients with chronic kidney disease (CKD).

7. rrtjournal.biomedcentral.com rrtjournal.biomedcentral.com/articles/10.1186/s41100-022-00454-z

Effects of ferric citrate hydrate in patients with chronic kidney ... This study demonstrated that oral FC had a tendency to increase serum ferritin and TSAT, and controlled serum phosphate in CKD patients regardless of the ...

8. auryxiahcp.com auryxiahcp.com/hyperphosphatemia/ferric-citrate-reactions

Safety & Tolerability - AURYXIA® (ferric citrate) tablets AURYXIA has a proven safety profile. Explore the safety and tolerability profile for AURYXIA to see if it is right for your adult patients.

9. kidney-international.org kidney-international.org/article/S0085-2538(19)30977-9/fulltext

Ferric citrate: cardio- and renoprotective in chronic ... Ferric citrate treatment in the setting of chronic kidney disease has been associated with effective phosphate control, improved iron and hematologic ...