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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155673
• Other study ID #: GCS-100-CS-4003
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2014
• Last updated: December 22, 2016
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: December 2016
• Source: La Jolla Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Mountain Kidney and Hypertension Associates, PA	Asheville	North Carolina
United States	Denver Nephrology	Denver	Colorado
United States	California Institute of Renal Research	La Mesa	California
United States	Clinical Advancement Center, PLLC	San Antonio	Texas
United States	Southwest Clinical Research Institute, LLC	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
La Jolla Pharmaceutical Company

Country where clinical trial is conducted

United States, 

Outcome

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