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

Anemia of Chronic Kidney Disease Clinical Trial

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

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04543812
Study type Interventional
Source Panion & BF Biotech Inc.
Contact
Status Completed
Phase Phase 3
Start date October 14, 2020
Completion date December 16, 2022
View Details
See also
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