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Iron-Based Phosphate Binder
Ferric Citrate for Chronic Kidney Disease (FIT4KID Trial)
Phase 2
Recruiting
Led By Isidro B Salusky, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum phosphate within age appropriate normal levels
Ages 6 to 17 years (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This trial will assess the effects of therapy with FC on changes in iFGF23 levels in 160 pediatric patients with CKD stages 3-4. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo.
Who is the study for?
This trial is for children aged 6-17 with moderate chronic kidney disease (stages 3-4) who have normal phosphate levels and can swallow tablets. They should be on stable doses of certain medications like growth hormone or iron supplements for at least two weeks before the study starts, and they must be able to eat at least two meals a day.
What is being tested?
The trial is testing if ferric citrate (FC) affects a hormone called iFGF23 in kids with kidney disease over a year. It's a double-blind study, meaning neither the participants nor the researchers know who gets FC or placebo. Kids are randomly chosen to get either FC or fake pills that look like FC.
What are the potential side effects?
Possible side effects from ferric citrate may include digestive issues such as diarrhea or constipation, nausea, vomiting, and potential changes in blood tests related to iron levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood phosphate levels are normal for my age.
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I am between 6 and 17 years old.
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I can swallow pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety of Ferric Citrate
Tolerability of Ferric Citrate
iFGF23 levels
Secondary study objectives
Effects on 1,25 D
Effects on Ferritin
Effects on Hemoglobin
+2 moreSide effects data
From 2019 Phase 4 trial • 55 Patients • NCT0307986993%
Black stool
37%
Diarrhea
19%
Constipation
15%
Nausea, vomiting
15%
Itching/rash
15%
Upper Respiratory Infection
11%
Decreased appetite
7%
Abdominal pain
7%
Bloating/Gas
4%
Peritonitis
4%
Congestive heart failure exacerbation
4%
Placement of catheter for HD
4%
gallstone pancreatitis
4%
Abdominal swelling
4%
Chest pain
4%
Intertrochanteric fracture
4%
Right foot infection
4%
Right sided pleuroperitoneal leak
4%
Pneumonia
4%
Hemorrhagic cerebrovascular accident
4%
Abscess
4%
Chest Pain/Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ferric Citrate - Peritoneal Dialysis
Ferric Citrate - Hemodialysis
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
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.
Group II: Control ArmPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tetraferric tricitrate decahydrate
FDA approved
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,029 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,259 Total Patients Enrolled
Isidro B Salusky, MDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
61 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood ferritin level is less than 500 ng/ml and your transferrin saturation (TSAT) is less than 50%.Your kidney function, measured by GFR, is between 15-59 ml/min per 1.73 m2.My blood phosphate levels are normal for my age.I can eat at least two meals a day.I am between 6 and 17 years old.My hormone, vitamin D, iron, or anemia treatments have been the same for the last 2 weeks.We will check if you have been taking your medication as prescribed using a special system and by counting the pills you have left.I have had a recent physical exam and my vital signs are recorded.I have completed a questionnaire about my stomach and intestinal symptoms.I can provide a list of all my current medications.You need to collect your urine for a whole day to measure the levels of creatinine and phosphate in it.I can swallow pills.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
- Group 2: Control Arm
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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