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PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD

NCT04543812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-06-29

No results posted yet for this study

Summary

To assess the safety and effectiveness of PBF-1681 for the treatment of Iron Deficiency Anemia in patients with Non-Dialysis Dependent Chronic Kidney Disease.

Conditions

  • Anemia of Chronic Kidney Disease

Interventions

DRUG

Ferric citrate

Ferric citrate will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.

DRUG

Placebo

Matching placebo will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.

Sponsors & Collaborators

  • Panion & BF Biotech Inc.

    lead INDUSTRY

Principal Investigators

  • Mei-I Wu, MD, PhD · Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2022-10-28
Completion
2022-12-16

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT04543812 on ClinicalTrials.gov