Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D (NCT02492620) | Clinical Trial Compass
CompletedPhase 3
Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D
United States200 participantsStarted 2015-03
Plain-language summary
It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
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
. Age \>18 years at screening visit
. Serum phosphate \> or equal to 3.0 mg/dL obtained at screening
. CKD with eGFR \< or equal to 20 mL/min obtained at screening\*
. Hemoglobin (Hgb) \>8.0 g/dL obtained at screening
. TSAT \<55% obtained at screening
. Females of child bearing potential with negative serum pregnancy test obtained at screening
. Willing and able to give written informed consent
. Anticipated to have \> or equal to 8 weeks prior to need for initiating RRT in the opinion of the investigator
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
Serum phosphate value prior to starting renal replacement therapy
. Liver enzymes (ALT/AST) \>X3 times upper limit of normal at screening
. Use of IV iron, blood transfusions or ESA agents within 2 weeks prior to the screening visit and prior to the Day 1 visit.
. Evidence of acute kidney injury (i.e., no CKD) or planned need for RRT within 12 weeks of screening
. Scheduled kidney transplant within 24 weeks of screening
. Contra-indication to ferric citrate: iron overload syndrome, allergic reaction or known intolerance to ferric citrate
. Clinically significant medical condition felt to interfere with tolerance of oral medication
. Life expectancy \< 6 months or confirmed conviction that subject does NOT want to initiate RRT despite a decline in kidney function
. Active drug or alcohol dependence or abuse (excluding tobacco use or marijuana use) within the 12 months prior to screening (in the opinion of the PI)