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 range18 Years
SexALL
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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.
✓. 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.
✕
What they're measuring
1
Number of Participants Achieving a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality
. 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.