Ferric Citrate and Chronic Kidney Disease in Children

Chronic Kidney Diseases Clinical Trial

— FIT4KID  

Official title:

Phosphate Binder Therapy and Chronic Kidney Disease in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04741646
• Other study ID #: 1U01DK122013-01
• Secondary ID: 1U01DK12201322-0
• Status: Recruiting
• Phase: Phase 2
• Start date: May 16, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: JENNY BROOK, MS
• Phone: 310-7943144
• Email: jbrook[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 12 core clinical sites.

Description:

We will conduct a 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) 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 12 core clinical sites.

Schedule of Intervention: During the 12-month trial, participants will be given a daily fixed weight-based dose of FC.

Schedule for data collection/analyses to be performed:

Blood for primary outcome assessments will be collected at screening, baseline and at months 3, 6, 9, 12. Blood for safety assessments will be collected at the same intervals.

The primary analyses for this 2-arm trial will evaluate changes from baseline in iFGF23 levels over 12 months between the treatment and the placebo arms. The analysis will use a linear mixed-effects model, with random participant effects accounting for repeated measurements, random site effects accounting for clustering of participants into study sites, and a fixed treatment effect, which interacts with a time indicator (Months 3-12 vs. Months 1-3).

Primary objectives:

• To assess the effects of therapy with FC on changes in iFGF23 levels

• To determine safety and tolerability of FC.

Secondary objectives:

• To assess the effects of FC on anemia and indices of mineral and bone metabolism.

Primary Endpoint:

• Change in iFGF23 level

Safety and Tolerability Endpoints:

• Ability to safely tolerate FC

Secondary Endpoints:

• Change in anemia

• Change in the indices of mineral and bone metabolism

This is a Phase 2 study with participation from 12 sites that will take 36 months to complete enrollment and a total of 48 months to complete data collection with each participant being part of the study for 12 months.

Study website: fit4kid.dgsom.ucla.edu

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Ages 6 to 18 years (inclusive);

2. Estimated Glomerular Filtration Rate (GFR) of 15-59 ml/min per 1.73 m2 by modified Chronic Kidney disease in Children (CKiD) formula;56

3. Serum phosphate within age appropriate normal levels;

4. Serum ferritin <500 ng/ml and TSAT <50%;

5. 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;

6. Able to swallow tablets;

7. Able to eat at least two meals a day;

8. 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:

1. Patients currently treated with phosphate binders.

2. History of allergy to all ingredients (including non-medical ingredients) in both products (i.e. investigational product and placebo)

3. 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

4. Anticipated initiation of dialysis or kidney transplantation within 6 months

5. Current or planned future systemic immunosuppressive therapy

6. Prior solid organ transplantation

7. Receipt of bone marrow transplant within two years of screening

8. Current pregnancy, lactation or female subjects who have reached menarche, unless using highly-effective contraception as outlined in section 7.1.1 of Protocol

9. Patients participating in other interventional study (observational study participation permitted)

10. Poor adherence to medical treatments in the opinion of the investigator

11. Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome

12. Cystinosis

13. Fanconi syndrome

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Ferric Citrate
Auryxia® 210 mg ferric iron tablets equivalent to 1 g of FC and matching placebo will be supplied as 200 tablets in 400cc high-density polyethylene bottles.
• Placebo
Placebo to match Ferric Citrate tablets

Locations

Country	Name	City	State
Canada	BC Children's Hospital Research Institute	Vancouver	British Columbia
United States	Emory University	Atlanta	Georgia
United States	Children's Hospital at Montefiore	Bronx	New York
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Medical Center, Dallas	Dallas	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	UTH	Houston	Texas
United States	Children's Mercy Hospital, Kansas City	Kansas City	Missouri
United States	University of California, Los Angeles	Los Angeles	California
United States	Arnold Palmer Hospital for Children	Orlando	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iFGF23 levels	Change in iFGF23 levels	6 months and 12 months
Primary	Safety of Ferric Citrate	Safety of FC will be compared to Placebo through measures of Adverse Events	12 months
Primary	Tolerability of Ferric Citrate	Tolerability of FC will be compared to Placebo through measures of Adverse Events	12 months
Secondary	Effects on Hemoglobin	Increase in Hemoglobin will be compared between FC and Placebo	12 months
Secondary	Effects on Transferrin Saturation (TSAT)	Increase in TSAT will be compared between FC and Placebo	12 months
Secondary	Effects on Ferritin	Increase in Ferritin will be compared between FC and Placebo	12 months
Secondary	Effects on Parathyroid Hormone(PTH)	Increase in PTH will be compared between FC and Placebo	12 months
Secondary	Effects on 1,25 D	Decrease in 1,25 D will be compared between FC and Placebo	12 months