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

NCT05085275 | Completed Phase 3 Results FDA Drug

• 1 other identifier: USRC-2021-002
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

Anemia, Iron Deficiency; Hyperphosphatemia; Renal Insufficiency, Chronic; Renal Anemia; Disease Progression; Cardiovascular; Iron

Keywords

ferric citrate

Outcome Measures

Primary Outcomes (1)

• 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

  9 months

Secondary Outcomes (3)

• 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)

  9 months

• Component of Primary - Initiation of Maintenance Dialysis

  9 months

• Component of Primary - All-Cause Mortality

  9 months

Study Arms (2)

Ferric citrate

EXPERIMENTAL

Supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.

Drug: Ferric Citrate 1 GM Oral Tablet [AURYXIA]

Placebo

PLACEBO COMPARATOR

Tablets, matching in color and size to ferric citrate.

Drug: Placebo

Interventions

Ferric Citrate 1 GM Oral Tablet [AURYXIA] DRUG

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.

Also known as: Auryxia

Ferric citrate

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Evidence of a clinically active infection requiring antibiotics at Randomization.
• Unable to comply with study requirements or in the opinion of the Investigator, not clinically stable to participate in the study.
• Use of an investigational medication or participation in an investigational study within 30 days prior to Day 1.
• Patients with a scheduled date for receipt of living donor kidney transplant

Sponsors & Collaborators

• USRC Kidney Research: lead
• Akebia Therapeutics: collaborator

Study Sites (23)

Arkansas Nephrology & Hypertension Clinic

Pine Bluff, Arkansas, 71603, United States

Location

Balboa Research SMO

Chula Vista, California, 91910, United States

Location

Balboa Research SMO

El Centro, California, 92243, United States

Location

Balboa Research SMO

Escondido, California, 92025, United States

Location

Balboa Research SMO

La Mesa, California, 91942, United States

Location

Balboa Research SMO - Kearney Mesa

San Diego, California, 92111, United States

Location

Rocky Mountain Kidney Care

Lone Tree, Colorado, 80124, United States

Location

Associates in Nephrology

Fort Myers, Florida, 33908, United States

Location

Dialysis Clinic, Inc.

Albany, Georgia, 31701, United States

Location

Nephrology and Hypertension Specialists, PC

Dalton, Georgia, 30720, United States

Location

Major Health Partners

Shelbyville, Indiana, 46176, United States

Location

Kidney Associates of Kansas City

Kansas City, Missouri, 64131, United States

Location

Nephrology-Hypertension Associates of Central NJ

South River, New Jersey, 08882, United States

Location

High Desert Nephrology Associates

Gallup, New Mexico, 87301, United States

Location

Nephrology Associates of Western NY

Amherst, New York, 14228, United States

Location

Spartanburg Nephrology Associates

Spartanburg, South Carolina, 29302, United States

Location

Dialysis Clinic, Inc.

Knoxville, Tennessee, 37920, United States

Location

South Texas Renal Care Group

Live Oak, Texas, 78233, United States

Location

South Texas Renal Care Group

San Antonio, Texas, 78202, United States

Location

South Texas Renal Care Group

San Antonio, Texas, 78211, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States

Location

South Texas Renal Care Group

San Antonio, Texas, 78221, United States

Location

South Texas Renal Care Group

San Antonio, Texas, 78251, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Hyperphosphatemia; Renal Insufficiency, Chronic; Disease Progression

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Phosphorus Metabolism Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Brillhart, Senior Director Regulatory Compliance
• Organization: USRC Kidney Research

stephanie.brillhart@usrenalcare.com

303-881-9451

Study Officials

• Geoff Block, MD

  USRC Kidney Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized, placebo controlled, double-blind, parallel assignment

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 20, 2021
• Study Start: March 30, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: August 29, 2025
• Results First Posted: August 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)