Ferric Citrate for Chronic Kidney Disease
Recruiting in Palo Alto (17 mi)
+12 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Keryx Biopharmaceuticals
Disqualifiers: Active GI disorder, Liver transaminases, Organ transplant, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
12346What 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.
12347Eligibility Criteria
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.
+8 more
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.
+11 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Ferric citrateExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Phoenix Childrens HospitalPhoenix, AZ
University of South FloridaTampa, FL
Seattle Children's HospitalSeattle, WA
University of MinnesotaMinneapolis, MN
More Trial Locations
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Who Is Running the Clinical Trial?
Keryx BiopharmaceuticalsLead Sponsor
References
Ferric citrate spans mineral metabolism and anemia domains in ESRD: a review of efficacy and safety data. [2015]Ferric citrate (Zerenex™, Keryx Biopharmaceuticals, Inc.), a phosphate binder drug candidate, recently completed a Phase III program confirming efficacy and demonstrating safety when used to treat hyperphosphatemia in patients with end-stage renal disease. Results of these trials demonstrate that ferric citrate effectively controls serum phosphorus and is well tolerated. Additionally, these studies demonstrate that ferric citrate improves iron parameters and reduces IV iron and erythropoietin stimulating agent utilization while maintaining hemoglobin levels. These unique features may further benefit the management of end-stage renal disease-related anemia.
Ferric citrate (auryxia) for the treatment of hyperphosphatemia. [2020]Ferric citrate (Auryxia) for the treatment of hyperphosphatemia.
Mechanism of Action and Clinical Attributes of Auryxia® (Ferric Citrate). [2021]Chronic kidney disease (CKD) is a major cause of morbidity and premature mortality and represents a significant global public health issue. Underlying this burden are the many complications of CKD, including mineral and bone disorders, anemia, and accelerated cardiovascular disease. Hyperphosphatemia and elevated levels of fibroblast growth factor 23 (FGF23) have been identified as key independent risk factors for the adverse cardiovascular outcomes that frequently occur in patients with CKD. Auryxia® (ferric citrate; Keryx Biopharmaceuticals, Inc., Boston, MA, USA) is an iron-based compound with distinctive chemical characteristics and a mechanism of action that render it dually effective as a therapy in patients with CKD; it has been approved as a phosphate binder for the control of serum phosphate levels in adult CKD patients treated with dialysis and as an iron replacement product for the treatment of iron deficiency anemia in adult CKD patients not treated with dialysis. This review focuses on Auryxia, its mechanism of action, and the clinical attributes that differentiate it from other, non-pharmaceutical-grade, commercially available forms of ferric citrate and from other commonly used phosphate binder and iron supplement therapies for patients with CKD. Consistent with the chemistry and mechanism of action of Auryxia, multiple clinical studies have demonstrated its efficacy in both lowering serum phosphate levels and improving iron parameters in patients with CKD. Levels of FGF23 decrease significantly with Auryxia treatment, but the effects associated with the cardiovascular system remain to be evaluated in longer-term studies.
Ferric citrate: a novel phosphate-binding agent. [2019]Ferric citrate (KRX-0502; Keryx Biopharmaceuticals, Inc., NY, USA) is a novel phosphate-binding agent presently in Phase III clinical development. Ferric citrate dissociates in the bowel lumen releasing the ferric ion to precipitate with dietary phosphorus, which is then excreted in the stool. Studies to date have shown the agent to be efficacious and safe with only mild gastrointestinal side effects. Absorption of either component of the agent (ferric iron or citrate) has the potential to be of benefit for patients with end-stage renal disease. An ongoing Phase III trial is confirming the safety and efficacy of ferric citrate as a phosphate binder in dialysis patients.
Ferric citrate hydrate, a new phosphate binder, prevents the complications of secondary hyperparathyroidism and vascular calcification. [2015]Ferric citrate hydrate (JTT-751) is being developed as a treatment for hyperphosphatemia in chronic kidney disease patients, and shows serum phosphorus-reducing effects on hyperphosphatemia in hemodialysis patients. We examined whether JTT-751 could reduce phosphorus absorption in normal rats and prevent the progression of ectopic calcification, secondary hyperparathyroidism and bone abnormalities in chronic renal failure (CRF) rats.
Usefulness of Oral Ferric Citrate in Patients With Iron-Deficiency Anemia and Chronic Kidney Disease With or Without Heart Failure. [2019]Patients with chronic inflammatory conditions including chronic kidney disease (CKD) and heart failure (HF) are undertreated with iron-deficiency anemia (IDA). Progressive inflammation and reduced iron transport associated with CKD and HF may reduce the efficacy of oral iron therapy. Oral ferric citrate improves anemia markers in CKD, but its effects in patients with CKD and concomitant HF have not been described. Patients with CKD not on dialysis and IDA from a phase 2 and 3 trial were treated with ferric citrate (n = 190) or placebo (n = 188); patients with HF were identified from medical histories. Hemoglobin response was defined as a ≥10.0-g/L increase in hemoglobin. Changes in hemoglobin, transferrin saturation, ferritin, and serum phosphate from baseline to week 12 and the incidence of adverse events potentially related to HF were evaluated. HF was reported in 22% (n = 81) of patients. The proportion of patients with hemoglobin response to ferric citrate treatment did not significantly differ in patients with and without HF (43% vs 49%, respectively; p = 0.47); changes from baseline in hemoglobin, iron parameters, and serum phosphate were similar. Adverse events potentially related to HF were noted more frequently in patients with HF (ferric citrate, 23%; placebo, 17%) versus those without HF (ferric citrate, 12%; placebo, 11%). In conclusion, these results indicate a potential role for ferric citrate in the treatment of IDA in patients with CKD not on dialysis and concomitant HF.
Ferric citrate hydrate for the treatment of hyperphosphatemia in nondialysis-dependent CKD. [2022]Ferric citrate hydrate is a novel iron-based phosphate binder being developed for hyperphosphatemia in patients with CKD.