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

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: GCS-100

• Registration Number: NCT02155673
• Lead Sponsor: La Jolla Pharmaceutical Company

Brief 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2016-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
2. Subject was enrolled in and completed the End of Study (Day 85) of GCS-100-CS-4002

Exclusion Criteria

1. Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4002

2. Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≤100 mmHg at screening

3. Subject has clinical laboratory results of:

   1. Hemoglobin: ≤9g/dL
   2. Total bilirubin: >1.5X the upper limit of normal (ULN)
   3. ALT and/or AST: >2.5X ULN

4. Subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk

5. Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose GCS-100	GCS-100	Low dose of GCS-100
High Dose GCS-100	GCS-100	GCS-100 High dose

Primary Outcome Measures

Name	Time	Method
Evaluation of Safety	Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period.	Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values

Trial Locations

Locations (5)

California Institute of Renal Research; 🇺🇸 La Mesa, California, United States

Denver Nephrology; 🇺🇸 Denver, Colorado, United States

Mountain Kidney and Hypertension Associates, PA; 🇺🇸 Asheville, North Carolina, United States

Clinical Advancement Center, PLLC; 🇺🇸 San Antonio, Texas, United States

Southwest Clinical Research Institute, LLC; 🇺🇸 Tempe, Arizona, United States