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New treatment option for Chronic Kidney Diseases
Official title Ferric Citrate and Chronic Kidney Disease in Children
ClinicalTrials.gov ID: NCT04741646
What this study is testing
What is Ferric Citrate?
Ferric Citrate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Also referred to as Auryxia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- Ages 6 to 18 years (inclusive);
- Estimated Glomerular Filtration Rate (GFR) of 15-59 ml/min per 1.73 m2 by modified Chronic Kidney disease in Children (CKiD) under 25 (U25) formula;56
- Serum phosphate \<=5.9 mg/dl;
- Serum ferritin \<500 ng/ml and TSAT \<50%;
- For those patients treated with growth hormone, calcitriol, nutritional vitamin D, iron, and/or erythropoiesis-stimulating agents (ESAs) such...
You likely can't join if
- Patients currently treated with phosphate binders.
- History of allergy to all ingredients (including non-medical ingredients) in both products (i.e. investigational product and placebo)
- Current intestinal malabsorption, documented in the medical record; disease, inflammatory bowel syndrome, and/or Crohn's Disease.
- Anticipated initiation of dialysis or kidney transplantation within 6 months
- Current or planned future systemic immunosuppressive therapy
- Prior solid organ transplantation
See the full eligibility criteria
- Ages 6 to 18 years (inclusive);
- Estimated Glomerular Filtration Rate (GFR) of 15-59 ml/min per 1.73 m2 by modified Chronic Kidney disease in Children (CKiD) under 25 (U25) formula;56
- Serum phosphate \<=5.9 mg/dl;
- Serum ferritin \<500 ng/ml and TSAT \<50%;
- For those patients treated with growth hormone, calcitriol, nutritional vitamin D, iron, and/or erythropoiesis-stimulating agents (ESAs) such treatments must have stable dosing for at least 2 weeks prior to screening;
- Able to swallow tablets;
- Able to eat at least two meals a day;
- In the opinion of the investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.
- Patients currently treated with phosphate binders.
- History of allergy to all ingredients (including non-medical ingredients) in both products (i.e. investigational product and placebo)
- Current intestinal malabsorption, documented in the medical record; disease, inflammatory bowel syndrome, and/or Crohn's Disease.
- Anticipated initiation of dialysis or kidney transplantation within 6 months
- Current or planned future systemic immunosuppressive therapy
- Prior solid organ transplantation
- Receipt of bone marrow transplant within two years of screening
- Current pregnancy, lactation or female people who have reached menarche, unless using highly-effective contraception as outlined in section 7.1.1 of Protocol
- Patients participating in other treatment study (observational study participation permitted)
- Poor adherence to medical treatments in the opinion of the investigator
- Cystinosis
- Fanconi syndrome
- Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- New York, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.