A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis (NCT01191255) | Clinical Trial Compass
CompletedPhase 3
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
United States, Israel, Puerto Rico441 participantsStarted 2010-10
Plain-language summary
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or non-pregnant, non-breast-feeding females
. Age ≥18 years
. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
. Serum phosphorus ≥6.0 mg/dL for study entry
. Taking less than 3-18 pills/day of current phosphate binder
. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
. Willing and able to give informed consent
. Life expectancy \>1 year
Exclusion criteria
. Parathyroidectomy within six months prior to Screening
. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
. History of multiple drug allergies or intolerances
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)