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.
This multicenter, randomized, double-blind, placebo-controlled clinical trial is being conducted to determine the effect of ferric citrate on the time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality in patients with non-dialysis dependent, advanced CKD. Up to 400 subjects will be randomized in 1:1 ratio to receive either ferric citrate or matching placebo. All subjects will initiate dosing at 2 tablets per meal or snacks, up to 3 times per day (maximum of 6 tablets per day). The dose of ferric citrate/placebo will only be adjusted based on safety and/or tolerability. Given the double-blind design of this trial, investigators will be instructed to not prescribe commercial Auryxia to either study arm. Study visits during the treatment period are to be conducted as part of routine scheduled clinical encounters. Standard of care local laboratory results will be collected however no study specific laboratory tests other than a pregnancy test in women of child-bearing potential will be required.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
289
All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed.
All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed.
Arkansas Nephrology & Hypertension Clinic
Pine Bluff, Arkansas, United States
Balboa Research SMO
Chula Vista, California, United States
Balboa Research SMO
El Centro, California, United States
Balboa Research SMO
Escondido, California, United States
Balboa Research SMO
La Mesa, California, United States
Balboa Research SMO - Kearney Mesa
San Diego, California, United States
Rocky Mountain Kidney Care
Lone Tree, Colorado, United States
Associates in Nephrology
Fort Myers, Florida, United States
Dialysis Clinic, Inc.
Albany, Georgia, United States
Nephrology and Hypertension Specialists, PC
Dalton, Georgia, United States
...and 13 more locations
Number of Participants Achieving a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality
Number of participants achieving a composite endpoint of initiation of maintenance dialysis or all-cause mortality
Time frame: 9 months
Hospitalization Events Reported as a Serious Adverse Event (SAE) (Excluding Disease-related Hospitalization [e.g., Dialysis Access Placement, Dialysis Initiation, Kidney Transplant] and Elective Procedures)
Number of hospitalization events reported as a serious adverse event (SAE) (excluding disease-related hospitalization \[e.g., dialysis access placement, dialysis initiation, kidney transplant\] and elective procedures)
Time frame: 9 months
Component of Primary - Initiation of Maintenance Dialysis
Component of Primary - Number of participants initiating maintenance dialysis
Time frame: 9 months
Component of Primary - All-Cause Mortality
Component of Primary - Number of patients reaching endpoint of all-cause mortality.
Time frame: 9 months
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