Phosphate Binder Therapy and Chronic Kidney Disease in Children
M
Myda Khalid
Primary Investigator
Enrolling By Invitation
6 years - 18 years
All
Phase
N/A
1 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The purpose of this placebo-controlled study is to determine how well ferric citrate will lower the level of FGF23, maintain or correct anemia and iron levels in the blood and maintain normal levels of serum phosphate in children with CKD stages 3 and 4 that is, between 15% and 60% of normal function. Ferric citrate is an oral medication that is approved by the U.S. Food and Drug Administration (FDA) for use in adults with kidney disease to control serum phosphate levels, but it has not been approved for use in children. The use of ferric citrate is considered investigational, which means it has not been approved for the way it is being used in this study.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
What will happen during the study?
- Participants will be randomly assigned by a computer program to one of two groups (like a flip of a coin); ferric
- citrate or placebo.
- Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
- You have an equal chance (50:50) of receiving placebo or active study drug.
- You will continue to receive your Standard of Care medications you are currently taking.
This study will test the following in children with CKD stages 3-4:
• The effectiveness of ferric citrate in lowing blood levels of FGF23.
• How well ferric citrate is tolerated over a 12-month period.
• The effects of ferric citrate on anemia, bone mineral metabolism and kidney function over a 12-month period.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Kidney Disease, CKD, Riley
-
Age: 6 years - 18 years
-
Gender: All
Inclusion Criteria:
- Estimated Glomerular Filtration Rate (GFR) of 15-59 ml/min per 1.73 m2 by modified Chronic Kidney disease in Children (CKiD) formula;56</li>
- Serum phosphate within age appropriate normal levels;
- 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.
Exclusion Criteria:
- 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; significant GI disorders including GI bleeding or active inflammatory bowel 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 subjects who have reached menarche, unless using highly-effective contraception as outlined in section 7.1.1 of Protocol
- Patients participating in other interventional study (observational study participation permitted)
- Poor adherence to medical treatments in the opinion of the investigator
- Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome
- Cystinosis
- Fanconi syndrome
Updated on
13 Jan 2025.
Study ID: PNEPH-UCLA-FIT-4-KIDS, 19921
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