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Ferric Citrate for Chronic Kidney Disease (FIT4KID Trial)
FIT4KID Trial 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.
FIT4KID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFIT4KID Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 4 trial • 55 Patients • NCT03079869FIT4KID Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment Arm
- Group 2: Control Arm
- 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.
- 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.
Frequently Asked Questions
Are patients currently being enrolled in this clinical trial?
"That is correct, the clinical trial described on clinicaltrials.gov is currently looking for patients to enroll. The first posting was on May 16th, 2022 and the most recent update was September 1st, 2022. In total, they need 160 participants from 12 different sites."
What are the primary goals of this particular clinical trial?
"The primary outcome variable that will be assessed over the course of 6 and 12 months is Ferric Citrate's Tolerability. Additionally, investigators will also compare FC to Placebo in terms of 1,25 D (Decrease), Ferritin (Increase), and Hemoglobin (Increase)."
How many people are involved in this experiment?
"One hundred and sixty individuals that meet the pre-specified inclusion criteria are needed to complete this clinical trial. Patients can choose to participate at St. Christopher's Hospital for Children in Philadelphia, Pennsylvania or Emory University in Atlanta, Georgia (among other sites)."
What is the innovation behind this clinical trial?
"Ferric Citrate has been trialed 5 times in the last year across 29 cities and 3 countries. The first study was completed in 2020 by Panion & BF Biotech Inc. In total, 200 participants were involved in the Phase 3 drug approval process. Since then, 18305 other trials have concluded."
Can minors join this clinical trial?
"This particular study is only for children aged 6 to 17. Out of the 477 clinical trials that exist for people over 65, this one is special because it includes 46 trials specifically designed for children."
What are some common applications of Ferric Citrate?
"Ferric Citrate is a medication most often used to treat hyperphosphataemia. It can also help patients who suffer from conditions like chronic kidney disease and dialysis therapy, but are not currently on dialysis."
At how many hospitals or research centers is this investigation being conducted?
"In addition to St. Christopher's Hospital for Children in Philadelphia, Pennsylvania, Emory University in Atlanta, Georgia, and University of California, Los Angeles in Los Angeles, California; this clinical trial is also being conducted at 12 other medical facilities."
Is this the first time that Ferric Citrate has been tested in a clinical setting?
"Ferric Citrate was first trialed in 2020 at the Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital. So far, a total of 18305 studies have been completed. There are 5 active studies currently underway--a large number taking place in Philadelphia, Pennsylvania."
What governmental agency regulates Ferric Citrate?
"While Phase 2 trials don't have data supporting efficacy, Ferric Citrate has some safety data, so it received a score of 2."
Could I potentially qualify to participate in this research?
"This clinical trial is looking for 160 participants aged 6-17 who suffer from kidney disease. In addition, the following must be true of potential patients: they must be willing and able to follow the study treatment and comply with recommendations from site investigators; have a normal level of serum phosphate; have a ferritin level below 500 ng/ml and TSAT level below 50%; if they are being treated with growth hormone, calcitriol, nutritional vitamin d, iron or ESAs, those treatments must have had stable dosing for at least 2 weeks prior to screening; finally, they must be able to swallow tablets and eat at least two"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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