RECRUITING

Ferric Citrate and Chronic Kidney Disease in Children

Conditions

Chronic Kidney Diseases Pediatric CKD Phosphate Binder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phosphate Binder Therapy and Chronic Kidney Disease in Children

Quick Facts

Study Start:2022-05-16

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04741646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

JENNY BROOK, MS

CONTACT

310-7943144

jbrook@mednet.ucla.edu

Barbara Gales, RN

CONTACT

bgales@mednet.ucla.edu

Principal Investigator

Isidro B Salusky, MD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

Children's Hospital of Orange County

Orange, California, 92868

United States

University of California, San Francisco

San Francisco, California, 94143

United States

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

United States

Emory University

Atlanta, Georgia, 30322

United States

Indiana U

Indianapolis, Indiana, 46202

United States

Children's Mercy Hospital, Kansas City

Kansas City, Missouri, 64110

United States

Washington U

Saint Louis, Missouri, 63130

United States

Cohen's Childrens

New York, New York, 11040

United States

Children's Hospital at Montefiore

The Bronx, New York, 10467

United States

Duke

Durham, North Carolina, 27708

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Nationwide Children's

Columbus, Ohio, 43205

United States

OHSU

Portland, Oregon, 97239

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Children's Medical Center, Dallas

Dallas, Texas, 75235

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

UTH

Houston, Texas, 77030

United States

UTH

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Isidro B Salusky, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-16

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2022-05-16

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

Pediatric
CKD
Phosphate Binder

Additional Relevant MeSH Terms

Chronic Kidney Diseases