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Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants

NCT04922645 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2022-11-07

No results posted yet for this study

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.

Conditions

  • Hyperphosphatemia
  • Anemia, Iron Deficiency
  • Renal Insufficiency

Interventions

DRUG

Ferric Citrate 1 gram Oral Tablet

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).

DRUG

Standard of care phosphate-lowering therapy

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.

Sponsors & Collaborators

  • Akebia Therapeutics Inc.

    collaborator UNKNOWN

  • USRC Kidney Research

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2022-09-15
Completion
2022-09-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04922645 on ClinicalTrials.gov