Chronic Kidney Disease Clinical Trial
Official title:
A Phase 2 Extension Study of Study GCS-100-CS-4002
The primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD.
Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with
adverse outcomes. Animal models with genetic knockout of galectin-3 demonstrate a reduction
in structural and functional deficits in the kidney. 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.
Study GCS-100-CS-4002 is an ongoing randomized, placebo controlled study of GCS-100 in Stage
3b and 4 CKD. The objective of the study is to determine the safety and efficacy of 8 weekly
injections of GCS-100 on eGFR. Patients who have completed that study without adverse safety
events, may be asked to participate in this study to test the safety of prolonged
administration of study drug.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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