PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD (NCT04543812) | Clinical Trial Compass
CompletedPhase 3
PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD
Taiwan141 participantsStarted 2020-10-14
Plain-language summary
To assess the safety and effectiveness of PBF-1681 for the treatment of Iron Deficiency Anemia in patients with Non-Dialysis Dependent Chronic Kidney Disease.
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
. Men or women ≥18 years of age at screening.
. CKD with eGFR \<60 mL/min at screening using the 4-variable Modification of Diet in Renal Disease equation, where up to 20% of subjects with eGFR \<15 mL/min are allowed.
. Hgb ≥9.0 g/dL and ≤11.5 g/dL at screening.
. Serum ferritin \<300 ng/mL and TSAT \<30% at screening.
. Serum iPTH ≤600 pg/mL at screening.
. Must consume minimally 2 meals per day.
. Willing to give written informed consent.
. Women may be enrolled if they are:
Exclusion criteria
. Cause of anemia other than iron deficiency.
. Serum phosphate \<3.0 mg/dL at screening.
. IV iron administered within 4 weeks of the start of screening.
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.
. ESA administered within 4 weeks of the start of screening.
. Blood transfusion within 4 weeks of the start of screening.
. Liver enzymes (alanine aminotransferase \[ALT\]/aspartate aminotransferase \[AST\]) \>3 times upper limit of normal (ULN) at screening.
. Symptomatic GI bleeding or symptomatic inflammatory bowel disease within 12 weeks of the start of screening.
. Concurrent GI diseases assessed by Investigators to be inappropriate for the study, eg, acute peptic ulcer, chronic ulcerative colitis, and regional enteritis.