NCT02155673

A Phase 2 Extension Study of Study GCS-100-CS-4002

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: La Jolla Pharmaceutical Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD.

Detailed description

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	GCS-100	1.5 mg/m2 or 30 mg/m2 GCS-100. GCS-100 will be administered as IV infusions once weekly for 8 weeks with a 1 week and 4 week follow-up period and then at least every 30 days for up to a total of 1 year.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2014-06-04
• Last updated: 2016-12-26

Locations

5 sites across 1 country: United States