Ferric Citrate and Chronic Kidney Disease in Children

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT04741646
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 17, 2022
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

iFGF23 levels [ Time Frame: 12 months ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Barbara Gales, RN
[email protected]
310-206-0799
Isidro Salusky, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Orange CountyOrangeCalifornia92868
Shoba Nayran, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Daniel Schrader
[email protected]
415-476-9657
Farzana Perwad, MD (PRINCIPAL_INVESTIGATOR)
Anthony Portale, MD (SUB_INVESTIGATOR)
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806
Estefania Bobe Cortes
[email protected]
3218424773
Jorge Ramirez, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Alexandria Wilkerson, BS
[email protected]
4047270851
Sabina Kennedy, MD (PRINCIPAL_INVESTIGATOR)
Indiana UIndianapolisIndiana46202
Sherry Wilson
[email protected]
khalid Myda, MD (PRINCIPAL_INVESTIGATOR)
Children's Mercy Hospital, Kansas CityKansas CityMissouri64110
Stephen Morrison
[email protected]
816-302-3573
Bradley Warady, MD (PRINCIPAL_INVESTIGATOR)
Washington USt LouisMissouri63130
Keith Hruska, MD (PRINCIPAL_INVESTIGATOR)
Cohen's ChildrensNew YorkNew York11040
Suzanne Vento
[email protected]
Christina Sethna, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital at MontefioreThe BronxNew York10467
Patricia Flynn
[email protected]
718-655-1120
Frederick Kaskel, MD (PRINCIPAL_INVESTIGATOR)
DukeDurhamNorth Carolina27708
Salma Sarah
[email protected]
919-681-1321
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Elizabeth Siry
[email protected]
513-636-7832
Mark Mitsnefes, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children'sColumbusOhio43205
John Mahan, MD (PRINCIPAL_INVESTIGATOR)
OHSUPortlandOregon97239
Jessica Stockton
[email protected]
Amira Al-Uzri, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Hannah Derwick
[email protected]
Michelle Denburg, MD (PRINCIPAL_INVESTIGATOR)
Children's Medical Center, DallasDallasTexas75235
Melaku Lemma
[email protected]
214-456-8577
Raymond Quigley, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Franca Ofudu
[email protected]
832-824-7391
Poyyapakkam R Srivanthos, MD (PRINCIPAL_INVESTIGATOR)
UTHHoustonTexas77030
Joyce Samuel, MD (PRINCIPAL_INVESTIGATOR)

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