Ferric Citrate for Chronic Kidney Disease

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

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (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 ferric citrate safe for humans?

Ferric citrate has been shown to be generally safe in humans, with studies reporting only mild gastrointestinal side effects. It has been tested in patients with chronic kidney disease and end-stage renal disease, demonstrating good tolerance and safety. ^{1 2 3 4 5}

What makes the drug Ferric Citrate unique for treating chronic kidney disease?

Ferric Citrate is unique because it acts as both a phosphate binder and an iron replacement therapy, effectively controlling serum phosphate levels and improving iron parameters in patients with chronic kidney disease. This dual action helps manage hyperphosphatemia and iron deficiency anemia, reducing the need for additional iron supplements and erythropoietin stimulating agents. ^{1 2 3 4 6}

What data supports the effectiveness of the drug Ferric Citrate for chronic kidney disease?

Ferric citrate has been shown to effectively control high phosphorus levels in patients with end-stage kidney disease and improve iron levels, which can help manage anemia. It also reduces the need for additional iron and anemia treatments, making it beneficial for kidney disease patients. ^{1 2 3 4 7}

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

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]

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]

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 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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Ferric citrate spans mineral metabolism and anemia domains in ESRD: a review of efficacy and safety data. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Ferric citrate (auryxia) for the treatment of hyperphosphatemia. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Mechanism of Action and Clinical Attributes of Auryxia&#174; (Ferric Citrate). [2021]

4. England pubmed.ncbi.nlm.nih.gov

Ferric citrate: a novel phosphate-binding agent. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Ferric citrate hydrate, a new phosphate binder, prevents the complications of secondary hyperparathyroidism and vascular calcification. [2015]

6. United States 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. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Ferric citrate hydrate for the treatment of hyperphosphatemia in nondialysis-dependent CKD. [2022]