NCT04543812

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Panion & BF Biotech Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Ferric citrate	Ferric citrate will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.
DRUG	Placebo	Matching placebo will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.

Timeline

• Start date: 2020-10-14
• Primary completion: 2022-10-28
• Completion: 2022-12-16
• First posted: 2020-09-10
• Last updated: 2025-06-29

Locations

12 sites across 1 country: Taiwan