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Clinical trial

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

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Last updated:9th Mar 2021
Status: Recruiting
Identifier: NCT04543812
PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD

Brief 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.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date: October 14, 2020
Estimated Primary Completion Date: November 2021
Estimated Study Completion Date: March 2022

- Experimental: PBF-1681 (ferric citrate)
- Placebo Comparator: Placebo

Category Value
Study type(s) Interventional
Estimated enrolment 200
Actual Study start date 14 October 2020
Estimated Study Completion Date 01 March 2022

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