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

NCT05085275 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2025-08-29

Study results available
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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.

Conditions

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

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.

Sponsors & Collaborators

  • USRC Kidney Research

    lead NETWORK

  • Akebia Therapeutics

    collaborator INDUSTRY

Principal Investigators

  • Geoff Block, MD · USRC Kidney Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2024-01-24
Completion
2024-01-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT05085275 on ClinicalTrials.gov