NCT05085275

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: USRC Kidney Research · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-30
• Primary completion: 2024-01-24
• Completion: 2024-01-24
• First posted: 2021-10-20
• Last updated: 2025-08-29
• Results posted: 2025-08-29

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study