CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 289 enrolled
Drug / intervention
Ferric Citrate 1 GM Oral Tablet [AURYXIA] +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05085275
NCT05085275Phase 3Completed
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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

USRC Kidney Research·interventional·Posted Oct 20, 2021·Updated Aug 29, 2025

In Brief

A Phase 3 clinical trial evaluating Ferric Citrate 1 GM Oral Tablet [AURYXIA] and Placebo for Anemia, Iron Deficiency and 6 related conditions. Completed, enrolled 289 participants across 23 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Iron Deficiency, Hyperphosphatemia, Renal Insufficiency, Chronic, Renal Anemia, Disease Progression, Cardiovascular, Iron
CountriesUnited States
CollaboratorsAkebia Therapeutics

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 20, 2021
Enrollment StartMar 30, 2022
Primary CompletionJan 24, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.7 years ago

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.

Placebodrug

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.