NCT02312050

A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes

A Phase 2b, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: La Jolla Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in patients with chronic kidney disease caused by diabetes. The study will enroll approximately 375 patients at multiple centers located in the United States. Study duration is 6 months. Patients will be randomly assigned 1:1:1:1 to treatment with placebo (0.9% Sodium Chloride Injection, USP), 1 mg, 3 mg, or 9 mg GCS-100. All doses of study drug will be administered via intravenous (IV) push injection once weekly for 2 months (8 weeks), then every other week for an additional 4 months (16 weeks).

Detailed description

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 caused by diabetes.

Conditions

• Diabetic Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	GCS-100	1 mg, 3 mg, or 9 mg IV push injections
DRUG	Placebo

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2014-12-09
• Last updated: 2015-05-19

Locations

8 sites across 1 country: United States