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 range18 Years
SexALL
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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
Exclusion criteria
✕. 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.
What they're measuring
1
Serum phosphate value prior to starting renal replacement therapy
✕. 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)