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

June 24, 2025 updated by: Panion & BF Biotech Inc.

A Phase 3 Study of PBF-1681 Comprising a 16-week, Placebo-controlled, Double-blind Randomized Period and an 8-week, Open-label Extension Period for the Treatment of Iron Deficiency Anemia in Patients With Non-Dialysis Dependent CKD

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 3, 24-week, multicenter study in Taiwan, comprising a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label extension period, where all subjects receive PBF-1681 (ferric citrate) ("Extension Period"). The study will consist of 10 visits over a period of 24 weeks. There will be a screening period of up to 14 days. Approximately 200 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either PBF-1681 or matching placebo, at baseline.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Raymond Chuang, MS, PMP
  • Phone Number: 303 +886-2-2655-8218
  • Email: rchuang@pbf.com.tw

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 83301
        • Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
      • Keelung, Taiwan, 20401
        • Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
      • New Taipei City, Taiwan, 22060
        • Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
      • Taichung, Taiwan, 40433
        • Division of Nephrology, Department of Internal Medicine, China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Taipei Municipal Wanfang Hospital
      • Taipei, Taiwan
        • Taipei Medical University Hospital
      • Taipei, Taiwan, 11217
        • Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital
      • Taipei, Taiwan, 10002
        • Department of Integrated Diagnostics and Therapeutics, National Taiwan University Hospital
      • Taipei county, Taiwan, 23561
        • Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men or women ≥18 years of age at screening.
  2. CKD with eGFR <60 mL/min at screening using the 4-variable Modification of Diet in Renal Disease equation, where up to 20% of subjects with eGFR <15 mL/min are allowed.
  3. Hgb ≥9.0 g/dL and ≤11.5 g/dL at screening.
  4. Serum ferritin <300 ng/mL and TSAT <30% at screening.
  5. Serum iPTH ≤600 pg/mL at screening.
  6. Must consume minimally 2 meals per day.
  7. Willing to give written informed consent.

  8. Women may be enrolled if they are:

    1. Documented to be surgically sterile or postmenopausal (amenorrhea >1 year and follicle-stimulating hormone ≥30 mU/mL), or
    2. Practicing true abstinence for at least 28 days prior to study drug administration until 30 days after study drug administration and having a negative serum pregnancy test at screening, or
    3. Using 2 forms of highly effective contraception, out of which 1 should be a physical barrier (condom or diaphragm), and another method such as adequate hormonal method (eg, contraceptive implants, injectables, oral contraceptives) or non-hormonal methods (eg, intrauterine device, spermicidals) from screening or at least 2 weeks prior to study drug administration (whichever is earlier) until 30 days after the study drug administration and having a negative serum pregnancy test at screening.

Exclusion Criteria:

  1. Cause of anemia other than iron deficiency.
  2. Serum phosphate <3.0 mg/dL at screening.
  3. IV iron administered within 4 weeks of the start of screening.
  4. ESA administered within 4 weeks of the start of screening.
  5. Blood transfusion within 4 weeks of the start of screening.
  6. Liver enzymes (alanine aminotransferase [ALT]/aspartate aminotransferase [AST]) >3 times upper limit of normal (ULN) at screening.
  7. Symptomatic GI bleeding or symptomatic inflammatory bowel disease within 12 weeks of the start of screening.
  8. Concurrent GI diseases assessed by Investigators to be inappropriate for the study, eg, acute peptic ulcer, chronic ulcerative colitis, and regional enteritis.
  9. Active infection requiring systemic antimicrobial treatment such as antibiotics, antiviral, or antifungals at screening.
  10. Concomitant or prior malignancy, except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy.
  11. Subjects with known allergic reaction to previous oral iron therapy.
  12. Subjects who were intolerant to oral iron therapy.
  13. History of hemochromatosis.
  14. Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of the start of screening.
  15. Planned surgery or hospitalization (anticipated to last >72 hours) during the Randomized Period of the study other than dialysis access-related surgery.
  16. Any other medical condition that, in the Investigators' opinion, may disturb subject's completion or optimal participation of the study, act as a significant confounding variable, or carry significant risks to a subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PBF-1681 (ferric citrate)
PBF-1681 (ferric citrate) will be dosed two times a day with the 2 largest meals (preferred) or three times a day with meals.
Drug: Ferric citrate
Ferric citrate will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.
Placebo Comparator: Placebo
Matching placebo will be dosed two times a day with the 2 largest meals (preferred) or three times a day with meals.
Drug: Placebo
Matching placebo will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemoglobin (Hgb)
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in Hgb.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Transferring saturation (TSAT)
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in TSAT.
16 weeks
Ferritin
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in ferritin.
16 weeks
Serum Phosphate
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in serum phosphate.
16 weeks
Sustained increase in Hgb of ≥0.75 g/dL
Time Frame: 16 weeks
The proportion of subjects achieving a sustained increase in Hgb of ≥0.75 g/dL from baseline over any 4-week interval during the Randomization Period.
16 weeks
Proportion of Subjects with ≥1.0 g/dL Hgb Increase at any time point
Time Frame: 16 weeks
The proportion of subjects achieving an increase in Hgb of ≥1.0 g/dL at any time point between baseline and the end of the 16-week Randomized Period.
16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum calcium
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in serum calcium.
16 weeks
Serum bicarbonate
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in serum bicarbonate.
16 weeks
Serum iron
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in serum iron.
16 weeks
Unsaturated iron binding capacity (UIBC)
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in UIBC.
16 weeks
Total iron binding capacity (TIBC)
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in TIBC.
16 weeks
Hematocrit
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in hematocrit.
16 weeks
Intact parathyroid hormone (iPTH)
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in iPTH.
16 weeks
Fibroblast growth factor 23 (intact and C-terminal)
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in FGF23 (intact and C-terminal).
16 weeks
Serum aluminum
Time Frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in serum aluminum.
16 weeks
Sustained increase in Hgb
Time Frame: 16 weeks
The proportion of subjects achieving a sustained increase in Hgb of ≥0.75 g/dL from baseline over any 4-week interval during the Randomized Period, provided that an increase in Hgb of ≥1.0 g/dL had occurred during that 4-week interval
16 weeks
Increase in Hgb of ≥1.0 g/dL
Time Frame: 16 weeks
Time (in days) to first increase in Hgb of ≥1.0 g/dL from baseline.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Panion & BF Biotech Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mei-I Wu, MD, PhD, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBB00601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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