Anemia of Chronic Kidney DiseasePhase 3NCT04543812
PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD
A Phase 3 study testing Ferric citrate in people with Anemia of Chronic Kidney Disease, run by Panion & BF Biotech Inc. at 12 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Ferric citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 12 sitesTaiwan
- Study dates
- 14 Oct 2020to 16 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Taiwan12 sites
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, 83301
Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
Keelung, 20401
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
New Taipei City, 22060
Division of Nephrology, Department of Internal Medicine, China Medical University Hospital
Taichung, 40433
National Cheng Kung University Hospital
Tainan
Department of Integrated Diagnostics and Therapeutics, National Taiwan University Hospital
Taipei, 10002
Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital
Taipei, 11217
Taipei Medical University Hospital
Taipei
Taipei Municipal Wanfang Hospital
Taipei
Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital
Taipei County, 23561
Chang Gung Memorial Hospital, Linkou
Taoyuan
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Ferric citrate, Placebo
- Keywords
- Ferric Citrate, Anemia, Chronic Kidney Disease
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric citrateDrug
Ferric citrate will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.
PlaceboDrug
Matching placebo will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin (Hgb)
The mean change from baseline to the end of the Randomized Period in Hgb.
Measured: 16 weeks
Secondary outcomes (5)
Proportion of Subjects with ≥1.0 g/dL Hgb Increase at any time point
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.
Measured: 16 weeks
Transferring saturation (TSAT)
The mean change from baseline to the end of the Randomized Period in TSAT.
Measured: 16 weeks
Ferritin
The mean change from baseline to the end of the Randomized Period in ferritin.
Measured: 16 weeks
Serum Phosphate
The mean change from baseline to the end of the Randomized Period in serum phosphate.
Measured: 16 weeks
Sustained increase in Hgb of ≥0.75 g/dL
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start14 Oct 2020
- Primary completion28 Oct 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panion & BF Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mei-I Wu, MD, PhD, Study chair, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543812
- Sponsor's protocol ID
- PBB00601
- Status last verified
- Jun 2025
- First submitted
- 2 Sep 2020
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04543812
- Acronym / sponsor ID
- PBB00601
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- Ferric Citrate, Anemia, Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Panion & BF Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBF-1681 (ferric citrate) | Experimental | Drug: Ferric citratePBF-1681 (ferric citrate) will be dosed two times a day with the 2 largest meals (preferred) or three times a day with meals. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo will be dosed two times a day with the 2 largest meals (preferred) or three times a day with meals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric citrateFerric citrate will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels. | Drug | PBF-1681 (ferric citrate) |
| PlaceboMatching placebo will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels. | Drug | Placebo |
Primary outcome
Hemoglobin (Hgb)
Time frame: 16 weeks
The mean change from baseline to the end of the Randomized Period in Hgb.
5 secondary outcomes
Proportion of Subjects with ≥1.0 g/dL Hgb Increase at any time point
Time frame: 16 weeks
Transferring saturation (TSAT)
Time frame: 16 weeks
Ferritin
Time frame: 16 weeks
Serum Phosphate
Time frame: 16 weeks
Sustained increase in Hgb of ≥0.75 g/dL
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-I Wu, MD, PhD study chair
Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric citrate in people with Anemia of Chronic Kidney Disease, run by Panion & BF Biotech Inc. at 12 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (Hgb) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.