Chronic Kidney Disease Clinical Trial
Official title:
A Phase 2 Extension of Study GCS-100-CS-4003
The primary objective of this study is to determine the safety and tolerability of extended dosing with a fixed dose of GCS-100 3 mg IV push in patients with Chronic Kidney Disease (CKD).
Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with
adverse outcomes (de Boer et. al., 2011, Dang et. al., 2012, Fernandes Bertocchi et. al.,
2008, Henderson et. al., 2008). Animal models with genetic knockout of galectin-3
demonstrate a reduction in structural and functional deficits in the kidney (Dang et. al.,
2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). GCS-100 is a galectin-3
antagonist that has been shown to reduce fibrosis pre-clinically. Based on the role of
galectin-3 and fibrosis in kidney disease, the Sponsor believes GCS-100 may be effective at
treating patients with CKD.
This study will consist of a fixed dose of GCS-100 3mg IV push at least every 30 days for a
total of 1 year with a follow-up 4 weeks after the last dose is administered.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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