Ferric Citrate for Chronic Kidney Disease
(FIT4KID Trial)
Recruiting in Palo Alto (17 mi)
+21 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of California, Los Angeles
Must not be taking: Phosphate binders
Disqualifiers: Intestinal malabsorption, GI disorders, others
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?We will conduct a 12-month, double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary endpoint) in 160 pediatric patients (80 in each of the two arms) aged 6-18 years of either sex with chronic kidney disease (CKD) stages 3-4 and age-appropriate normal serum phosphate levels. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 20 core clinical sites.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on growth hormone, calcitriol, nutritional vitamin D, iron, or erythropoiesis-stimulating agents, your doses must be stable for at least 2 weeks before joining. You cannot participate if you are currently treated with phosphate binders.
What data supports the effectiveness of the drug Ferric Citrate for chronic kidney disease?
Ferric citrate has been shown to effectively control serum phosphorus levels and improve iron parameters in patients with chronic kidney disease, particularly those on dialysis. It also reduces the need for intravenous iron and erythropoietin stimulating agents, which are used to manage anemia, while maintaining hemoglobin levels.
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.
12456How is the drug Ferric Citrate unique for treating chronic kidney disease?
Ferric Citrate is unique because it not only helps control high phosphate levels in the blood, which is common in chronic kidney disease, but also improves iron levels and reduces the need for additional iron and anemia treatments. This dual action makes it different from other treatments that typically address only one of these issues.
12457Eligibility Criteria
This trial is for children aged 6-17 with moderate chronic kidney disease (stages 3-4) who have normal phosphate levels and can swallow tablets. They should be on stable doses of certain medications like growth hormone or iron supplements for at least two weeks before the study starts, and they must be able to eat at least two meals a day.Inclusion Criteria
Your blood ferritin level is less than 500 ng/ml and your transferrin saturation (TSAT) is less than 50%.
Your kidney function, measured by GFR, is between 15-59 ml/min per 1.73 m2.
My blood phosphate levels are normal for my age.
+5 more
Exclusion Criteria
Reinforce adherence
Administer the Medical Adherence Measure tool
Prepare one month's supply of drug and enter them into eCAP system
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive a daily fixed weight-based dose of Ferric Citrate or placebo for 12 months
12 months
Visits at baseline, months 3, 6, 9, 12 (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Participant Groups
The trial is testing if ferric citrate (FC) affects a hormone called iFGF23 in kids with kidney disease over a year. It's a double-blind study, meaning neither the participants nor the researchers know who gets FC or placebo. Kids are randomly chosen to get either FC or fake pills that look like FC.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
During the 12-month trial, participants will be given a fixed weight-based dose of Ferric Citrate (FC). The full medication dose will be 3g/day for participants weighing \<31 kg, 5g/day for those weighing \>31 - \<51 kg, and 6g/day for participants \>51 kg. These doses will be divided into three doses to be taken with meals.
Group II: Control ArmPlacebo Group1 Intervention
During the 12-month trial, participants will be given a fixed weight-based dose of Placebo. The full medication dose will be 3g/day for participants weighing \<31 kg, 5g/day for those weighing \>31 - \<51 kg, and 6g/day for participants \>51 kg. These doses will be divided into three doses to be taken with meals.
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:
UTHHouston, TX
Baylor College of MedicineHouston, TX
BC Children's Hospital Research InstituteVancouver, Canada
St. Christopher's Hospital for ChildrenPhiladelphia, PA
More Trial Locations
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
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: 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.
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 (auryxia) for the treatment of hyperphosphatemia. [2020]Ferric citrate (Auryxia) for the treatment of hyperphosphatemia.
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.