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Ferric Citrate for Chronic Kidney Disease (FRONTIER Trial)
FRONTIER Trial Summary
This trial found that ferric citrate may improve outcomes for people with advanced chronic kidney disease.
FRONTIER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFRONTIER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FRONTIER Trial Design
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Who is running the clinical trial?
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- I am currently taking antibiotics for an active infection.I am expected to start regular dialysis soon, within the next 8 weeks.My doctor thinks my kidney issues are due to a sudden injury, not chronic disease.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.Women who could become pregnant must have a negative pregnancy test within 28 days before starting the study.I am scheduled to receive a kidney transplant from a living donor.My kidney function is severely reduced, with an eGFR of 20 ml/min/1.73m2 or less.I am 18 years old or older.You had a bad reaction to iron pills in the past.I have a history of conditions causing too much iron in my blood.You are allergic to ferric citrate or any of its ingredients.Your recent transferrin saturation (TSAT) level is 45% or less within 45 days before the start of the study.Your ferritin blood level is 500 ng/mL or less within 45 days before the start of the trial.I am currently being treated for cancer, except for non-melanoma skin cancer.Your blood phosphate level is higher than 3.0 mg per dL within 45 days before the start of the study.
- Group 1: Ferric citrate
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
In how many different parts of the country is this trial being conducted?
"In total, there are 23 enrolment sites for this trial. These locations include Balboa Research SMO in La Mesa, California; Balboa Research SMO - Kearney Mesa in San Diego, New york; Nephrology Associates of Western NY in Amherst, Colorado; and 20 others."
Has this research been conducted before?
"At the moment, there are 5 ongoing clinical trials for Ferric Citrate 1 GM Oral Tablet [AURYXIA]. These international studies began in 2020 and have so-far been conducted across 29 cities in 3 countries. The first of these trials was completed as a Phase 3 drug approval stage sponsored by Panion & BF Biotech Inc.. In total, 200 participants were involved. Since 2020, a total of 18304 trials have been completed worldwide."
How many individuals are enrolled in this clinical trial presently?
"Yes, the information on clinicaltrials.gov indicates that this trial is presently looking for patients. The clinical trial was originally posted on 3/30/2022 and was most recently updated on 8/15/2022. The trial is looking for 400 participants at 20 locations."
What is the primary medical condition that Ferric Citrate 1 GM Oral Tablet [AURYXIA] has been known to improve?
"Ferric Citrate 1 GM Oral Tablet [AURYXIA] is a medication prescribed to patients with hyperphosphataemia. It can also help those not on dialysis, chronic kidney disease (ckd), anddialysis therapy."
Does the data on Ferric Citrate 1 GM Oral Tablet [AURYXIA] stand alone, or is it corroborated by other similar research?
"The first trials for Ferric Citrate 1 GM Oral Tablet [AURYXIA] were completed in 2020 at the Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital. Out of the 18304 total trials conducted, 5 are still active. The majority of these ongoing studies are taking place in La Mesa, California."
Are we currently enrolling new participants for this research?
"Yes, that is accurate. The clinical trial in question is still looking for patients, with 400 needed in total. 20 different locations are being used to find participants. The study was posted on March 30th, 2022 and updated on August 15th of the same year."
What sort of health risks does Ferric Citrate 1 GM Oral Tablet [AURYXIA] present?
"There is some evidence that Ferric Citrate 1 GM Oral Tablet [AURYXIA] is effective, and it has been through multiple rounds of testing for safety, so we give it a 3."
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