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

NCT04543812 | Completed Phase 3

• 1 other identifier: PBB00601
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 12

Brief 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

Keywords

Ferric Citrate; Anemia; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Hemoglobin (Hgb)

  The mean change from baseline to the end of the Randomized Period in Hgb.

  16 weeks

Secondary Outcomes (5)

• Proportion of Subjects with ≥1.0 g/dL Hgb Increase at any time point

  16 weeks

• Transferring saturation (TSAT)

  16 weeks

• Ferritin

  16 weeks

• Serum Phosphate

  16 weeks

• Sustained increase in Hgb of ≥0.75 g/dL

  16 weeks

Other Outcomes (11)

• Serum calcium

  16 weeks

• Serum bicarbonate

  16 weeks

• Serum iron

  16 weeks

Study Arms (2)

PBF-1681 (ferric citrate)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Matching placebo will be dosed two times a day with the 2 largest meals (preferred) or three times a day with meals.

Drug: Placebo

Interventions

Ferric citrate DRUG

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

PBF-1681 (ferric citrate)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥18 years of age at screening.
• 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.
• Hgb ≥9.0 g/dL and ≤11.5 g/dL at screening.
• Serum ferritin \<300 ng/mL and TSAT \<30% at screening.
• Serum iPTH ≤600 pg/mL at screening.
• Must consume minimally 2 meals per day.
• Willing to give written informed consent.
• Women may be enrolled if they are:
• Documented to be surgically sterile or postmenopausal (amenorrhea \>1 year and follicle-stimulating hormone ≥30 mU/mL), or
• 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
• 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.

You may not qualify if:

• Cause of anemia other than iron deficiency.
• Serum phosphate \<3.0 mg/dL at screening.
• IV iron administered within 4 weeks of the start of screening.
• ESA administered within 4 weeks of the start of screening.
• Blood transfusion within 4 weeks of the start of screening.
• Liver enzymes (alanine aminotransferase \[ALT\]/aspartate aminotransferase \[AST\]) \>3 times upper limit of normal (ULN) at screening.
• Symptomatic GI bleeding or symptomatic inflammatory bowel disease within 12 weeks of the start of screening.
• Concurrent GI diseases assessed by Investigators to be inappropriate for the study, eg, acute peptic ulcer, chronic ulcerative colitis, and regional enteritis.
• Active infection requiring systemic antimicrobial treatment such as antibiotics, antiviral, or antifungals at screening.
• Concomitant or prior malignancy, except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy.
• Subjects with known allergic reaction to previous oral iron therapy.
• Subjects who were intolerant to oral iron therapy.
• History of hemochromatosis.
• Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of the start of screening.
• Planned surgery or hospitalization (anticipated to last \>72 hours) during the Randomized Period of the study other than dialysis access-related surgery.

Sponsors & Collaborators

• Panion & BF Biotech Inc.: lead

Study Sites (12)

Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital

Keelung, 20401, Taiwan

Location

Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital

New Taipei City, 22060, Taiwan

Location

Division of Nephrology, Department of Internal Medicine, China Medical University Hospital

Taichung, 40433, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Department of Integrated Diagnostics and Therapeutics, National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Location

Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital

Taipei County, 23561, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mei-I Wu, MD, PhD

  Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: October 14, 2020
• Primary Completion: October 28, 2022
• Study Completion: December 16, 2022
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (12)