Loading clinical trials...

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Effect of Ferric Citrate on Time to a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality vs Placebo in Adults With Advanced CKD

NCT05085275•USRC Kidney Research

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult patients greater or equal to 18 years old.
•2. 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.
•3. Most recent transferrin saturation (TSAT) less than or equal to 45% within 45 days of Day 1.
•4. Most recent serum phosphate is greater or equal to 3.0 mg per dL within 45 days of Day 1.
•5. Most recent ferritin is less than or equal to 500 ng per mL within 45 days of Day 1.
•6. Women of child-bearing potential must have a negative serum or urine pregnancy test within 28 days prior to Day 1.
•7. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion Criteria

•1. Patients who, in the opinion of the Investigator, have acute kidney injury rather than CKD.
•2. 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.
•3. A known allergy or intolerance to ferric citrate or any of its constituents.
•4. Hypersensitivity reaction to previous oral iron therapy.
•5. History of hemochromatosis or iron overload syndrome (e.g., hereditary sideroblastic anemia, thalassemia, polycythemia vera).
•6. Active malignancy requiring current treatment except for non-melanoma skin cancer regardless of treatment.
•7. 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.
•8. Limited life expectancy (less than 6 months) in the opinion of the Investigator.
•9. Females who are known to be pregnant or are breast-feeding during Screening or are planning to become pregnant and breastfeeding during the study period.
•10. Evidence of a clinically active infection requiring antibiotics at Randomization.
+3 more criteria

Locations (23)

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

Key Dates

Start Date

March 30, 2022

Primary Completion Date

January 24, 2024

Completion Date

January 24, 2024

Last Updated

August 29, 2025

Enrollment

289

ACTUAL participants

Conditions

Anemia, Iron DeficiencyHyperphosphatemiaRenal Insufficiency, ChronicRenal AnemiaDisease ProgressionCardiovascularIron

Interventions

Ferric Citrate 1 GM Oral Tablet [AURYXIA]

DRUG

Placebo

DRUG

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

NCT06933472

HyperphosphatemiaChronic Kidney Disease, Receiving Dialysis+2 more

View study

RECRUITINGNA

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

NCT06314503

Renal Insufficiency, ChronicKidney Failure, Chronic+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

Inclusion Criteria

Exclusion Criteria

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial

Effects of Exogenous Ketosis on Proteinuria and Renal Function

IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

Penn Produce Prescription and Chronic Kidney Disease Study