CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 214 enrolled
Drug / intervention
Ferric Citrate 1 gram Oral Tablet +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/NCT04922645
NCT04922645Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Impact of Auryxia (Ferric Citrate) on Erythropoiesis-Stimulating Agent (ESA) Use, Intravenous (IV) Iron Use, Phosphate Control, and Anemia Control in Adult Participants on In-Center Hemodialysis or Home Dialysis

USRC Kidney Research·interventional·Posted Jun 10, 2021·Updated Nov 7, 2022

In Brief

A Phase 4 clinical trial evaluating Ferric Citrate 1 gram Oral Tablet and Standard of care phosphate-lowering therapy for Hyperphosphatemia and 2 related conditions. Completed, enrolled 214 participants across 13 sites.

Detailed Summary

This study is being conducted to demonstrate the effect of Auryxia, when used as the primary phosphate lowering therapy, on the overall cumulative use of erythropoiesis-stimulating agent and intravenous iron as well as on the laboratory parameters indicative of phosphate and anemia management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperphosphatemia, Anemia, Iron Deficiency, Renal Insufficiency
CountriesUnited States
CollaboratorsAkebia Therapeutics

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedJun 10, 2021
Enrollment StartJun 29, 2021
Primary CompletionSep 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.1 years ago

Interventions

Ferric Citrate 1 gram Oral Tabletdrug

Ferric citrate is an iron-based phosphate binder for the treatment of hyperphosphatemia in subjects with dialysis-dependent chronic kidney disease (DD CKD) and for the treatment of iron deficiency anemia (IDA) in subjects with non-dialysis dependent chronic kidney disease (NDD CKD).

Standard of care phosphate-lowering therapydrug

Subjects randomized to SOC will continue their currently prescribed dose of phosphate lowering therapy which will be dosed per local standard of care to achieve community target serum phosphate goals.