CompletedPhase 3

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

Taiwan141 participantsStarted 2020-10-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.

What they're measuring

Hemoglobin (Hgb)

Timeframe: 16 weeks

Trial details

NCT IDNCT04543812

SponsorPanion & BF Biotech Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-28

View on ClinicalTrials.gov More Anemia of Chronic Kidney Disease trials