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Triferic for Kidney Failure
Study Summary
This trial is testing whether it is safe to give Triferic iron to children with chronic kidney disease who are on dialysis.
- Kidney Failure
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Group 1: Triferic via IV and Hemodialysate
- Group 2: Historic Control Observational Arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Could I join this clinical trial?
"Up to 150 paediatric patients with chronic kidney disease, who have been receiving hemodialysis treatment for at least 3 months, and weigh more than 11lbs (5kg) are eligible for this study. Additional requirements include that the patient has a suitable vascular access for hemodialysis treatment and is between 6 months and 17 years old."
Are there any available positions for people who want to participate in this clinical trial?
"Yes, this trial is looking for participants and has been since September 1st, 2020 according to the information available on clinicaltrials.gov."
Has Triferic been cleared by the FDA?
"Triferic is estimated to be a safe medication, as it has received a score of 3. This is due in part because Triferic is a Phase 3 trial drug, meaning that there are multiple rounds of data supporting both its efficacy and safety."
How many total people have signed up to participate in this research project?
"This particular clinical study necessitates 150 individuals that fit the required profile. Locations where this research will take place include Riley Hospital for Children at Indiana University in Indianapolis, Indiana and Loma Linda University Hospital in Loma Linda, California - both of which are operated by the sponsor, Rockwell Medical Technologies, Inc.."
Are numerous hospitals in the United States conducting this research?
"A few of the 8 locations where this trial is recruiting patients include Riley Hospital for Children at Indiana University in Indianapolis, Indiana; Loma Linda University Hospital in Loma Linda, California; and Cincinnati Children's Hospital in Cincinnati, Ohio."
Are there other documented cases of Triferic's efficacy?
"Triferic's clinical trials are ongoing, with 1 Phase 3 study in progress. Most of these trials are based out of Kansas City, although there are 9 locations total running Triferic trials."
Is this the first time this type of trial has been conducted?
"Triferic has been under clinical scrutiny since 2020 when it was first studied by Rockwell Medical Technologies, Inc. Since then, there have been 150 participants in various trials leading up to its Phase 3 approval. Currently, there is one ongoing trial for Triferic being conducted by Rockwell Medical Technologies, Inc.."
If I am not yet a senior citizen, can I still qualify for this particular medical research program?
"The age requirements for potential participants in this study are that they must be between 6 months and 17 years old."
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