Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease (NCT05085275) | Clinical Trial Compass
CompletedPhase 3
Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease
United States289 participantsStarted 2022-03-30
Plain-language summary
A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality.
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
. Adult patients greater or equal to 18 years old.
. Diagnosis of NDD advanced CKD, regardless of etiology. Advanced CKD is defined as at least one local laboratory determined estimated glomerular filtration rate (eGFR) ≤20 ml/min/1.73m2 (calculated per any commonly used method or equation for estimating eGFR) within 90 days of Day 1.
. Most recent transferrin saturation (TSAT) less than or equal to 45% within 45 days of Day 1.
. Most recent serum phosphate is greater or equal to 3.0 mg per dL within 45 days of Day 1.
. Most recent ferritin is less than or equal to 500 ng per mL within 45 days of Day 1.
. Women of child-bearing potential must have a negative serum or urine pregnancy test within 28 days prior to Day 1.
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
Number of Participants Achieving a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality
. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Exclusion criteria
. Patients who, in the opinion of the Investigator, have acute kidney injury rather than CKD.
. Patients with planned/imminent maintenance dialysis, or that are anticipated to begin maintenance dialysis within 8 weeks from Screening, in the opinion of the Investigator.
. A known allergy or intolerance to ferric citrate or any of its constituents.
. Hypersensitivity reaction to previous oral iron therapy.
. History of hemochromatosis or iron overload syndrome (e.g., hereditary sideroblastic anemia, thalassemia, polycythemia vera).
. Active malignancy requiring current treatment except for non-melanoma skin cancer regardless of treatment.
. Active drug or alcohol dependence or abuse (excluding tobacco use or use of medical or recreational marijuana) within the 12 months prior to Screening or evidence of such abuse, in the opinion of the Investigator.
. Limited life expectancy (less than 6 months) in the opinion of the Investigator.