FIT4KID: Ferric Citrate and Chronic Kidney Disease in Children

Sponsor

University of California, Los Angeles (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04741646

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

160

Enrollment

Locations

Arms

Anticipated Duration (Months)

14.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 6-17 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Drug: Ferric Citrate Drug: Placebo	Phase 2

Detailed 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 6-17 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 1, 2, 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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phosphate Binder Therapy and Chronic Kidney Disease in Children

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm 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.	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 Comparator: Control Arm 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.	Drug: Placebo Placebo to match Ferric Citrate tablets

Arm

Intervention/Treatment

Experimental: Treatment Arm

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.

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 Comparator: Control Arm

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.

Drug: Placebo

Placebo to match Ferric Citrate tablets

Outcome Measures

Primary Outcome Measures

iFGF23 levels [6 months and 12 months]
Change in iFGF23 levels
Safety of Ferric Citrate [12 months]
Safety of FC will be compared to Placebo through measures of Adverse Events
Tolerability of Ferric Citrate [12 months]
Tolerability of FC will be compared to Placebo through measures of Adverse Events

Secondary Outcome Measures

Effects on Hemoglobin [12 months]
Increase in Hemoglobin will be compared between FC and Placebo
Effects on TSAT [12 months]
Increase in TSAT will be compared between FC and Placebo
Effects on Ferritin [12 months]
Increase in Ferritin will be compared between FC and Placebo
Effects on PTH [12 months]
Increase in PTH will be compared between FC and Placebo
Effects on 1,25 D [12 months]
Decrease in 1,25 D will be compared between FC and Placebo

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages 6 to 17 years (inclusive);
Estimated GFR of 15-59 ml/min per 1.73 m2 by modified CKiD formula;56
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 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:

Perform physical exam and obtain vitals.
Check urine pregnancy test in menstruating female participants and administer corresponding questionnaire.
Administer GI Symptom questionnaire.
Ascertain AEs.
Obtain information on concomitant medications.
Process 24-hour urine sample for 24 hour urine creatinine and phosphate.
Measure run-in adherence using eCAP system and pill count.
Administer the Medical Adherence Measure tool.
Reinforce adherence.
Prepare one month's supply of drug and enter them into eCAP system.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	University of California, San Francisco	San Francisco	California	United States	94143
3	Arnold Palmer Hospital for Children	Orlando	Florida	United States	32806
4	Emory University	Atlanta	Georgia	United States	30322
5	Children's Mercy Hospital, Kansas City	Kansas City	Missouri	United States	64110
6	Children's Hospital at Montefiore	Bronx	New York	United States	10467
7	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
8	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania	United States	19134
9	Children's Medical Center, Dallas	Dallas	Texas	United States	75235
10	Baylor College of Medicine	Houston	Texas	United States	77030
11	BC Children's Hospital Research Institute	Vancouver	British Columbia	Canada	V5Z 4H4

Sponsors and Collaborators

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

Investigators

Principal Investigator: Isidro B Salusky, MD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Isidro Salusky, MD, Distinguished Professor of Pediatrics at the David Geffen School of Medicine at UCLA, Chief of Pediatric Nephrology and Director of the Pediatric Dialysis Program, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT04741646

Other Study ID Numbers:

1U01DK122013-01

First Posted:

Feb 5, 2021

Last Update Posted:

Feb 5, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Isidro Salusky, MD, Distinguished Professor of Pediatrics at the David Geffen School of Medicine at UCLA, Chief of Pediatric Nephrology and Director of the Pediatric Dialysis Program, University of California, Los Angeles

Pediatric

CKD

Phosphate Binder

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Feb 5, 2021