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Clinical Trials List

Protocol NumberPBB00601
NCT Number(ClinicalTrials.gov Identfier)NCT04543812

2019-01-01 - 2023-06-30

Phase III

Recruiting1

Terminated11

ICD-10N18

Chronic kidney disease (CKD)

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

  • Trial Applicant

  • Sponsor

    Panion & BF Biotech Inc.

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Der-Cherng Tarng Division of Nephrology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Mai-Szu Wu Division of Nephrology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 李建德 Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 李進昌 Division of Nephrology
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 彭渝森 Division of Nephrology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chiz-Tzung Chang Division of Nephrology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yi wen chiu Division of Nephrology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator - - Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yuh-Mou Sue Division of Nephrology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chih-Chin Kao Division of Nephrology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chen-Chieh Hung Division of Nephrology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Ming-Cheng Wang Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Iron Deficiency Anemia With Non-Dialysis Dependent CKD

Objectives

1. To compare the efficacy and safety of PBF-1681 to placebo for the treatment of IDA in adult subjects with NDD-CKD as measured by the proportion of subjects achieving an increase in Hgb of ≥1.0 g/dL at any study point between baseline and the end of the Randomized Period; and 2. To determine the safety and tolerability of PBF-1681 in adult subjects with NDD-CKD as a treatment of IDA.

Test Drug

PBF-1681

Active Ingredient

Ferric citrate

Dosage Form

tablet

Dosage

1000

Endpoints

Primary Efficacy Endpoint
• 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
(Week 16).

Secondary Efficacy Endpoints
• The mean change from baseline to the end of the 16-week Randomized Period
in
A. Hgb;
B. TSAT;
C. Ferritin;
D. Serum phosphate; and
E. 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.

Inclution 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:
a. Documented to be surgically sterile or postmenopausal (amenorrhea
>1 year and follicle-stimulating hormone ≥30 mU/mL), or
b. 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
c. 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 <3.5 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.

The Estimated Number of Participants

  • Taiwan

    150 participants

  • Global

    150 participants

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