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

PHASE3CompletedINTERVENTIONAL
Enrollment

289

Participants

Timeline

Start Date

March 30, 2022

Primary Completion Date

January 24, 2024

Study Completion Date

January 24, 2024

Conditions
Anemia, Iron DeficiencyHyperphosphatemiaRenal Insufficiency, ChronicRenal AnemiaDisease ProgressionCardiovascularIron
Interventions
DRUG

Ferric Citrate 1 GM Oral Tablet [AURYXIA]

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.

DRUG

Placebo

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.

Trial Locations (23)

14228

Nephrology Associates of Western NY, Amherst

29302

Spartanburg Nephrology Associates, Spartanburg

30720

Nephrology and Hypertension Specialists, PC, Dalton

31701

Dialysis Clinic, Inc., Albany

33908

Associates in Nephrology, Fort Myers

37920

Dialysis Clinic, Inc., Knoxville

46176

Major Health Partners, Shelbyville

64131

Kidney Associates of Kansas City, Kansas City

71603

Arkansas Nephrology & Hypertension Clinic, Pine Bluff

78202

South Texas Renal Care Group, San Antonio

78211

South Texas Renal Care Group, San Antonio

78212

Clinical Advancement Center, PLLC, San Antonio

78221

South Texas Renal Care Group, San Antonio

78233

South Texas Renal Care Group, Live Oak

78251

South Texas Renal Care Group, San Antonio

80124

Rocky Mountain Kidney Care, Lone Tree

87301

High Desert Nephrology Associates, Gallup

91910

Balboa Research SMO, Chula Vista

91942

Balboa Research SMO, La Mesa

92025

Balboa Research SMO, Escondido

92111

Balboa Research SMO - Kearney Mesa, San Diego

92243

Balboa Research SMO, El Centro

08882

Nephrology-Hypertension Associates of Central NJ, South River

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Akebia Therapeutics

INDUSTRY

lead

USRC Kidney Research

NETWORK

NCT05085275 - Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease | Biotech Hunter | Biotech Hunter