A Phase 2 Extension of Study GCS-100-CS-4003

Chronic Kidney Disease Clinical Trial

Official title:

A Phase 2 Extension of Study GCS-100-CS-4003

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02333955
• Other study ID #: GCS-100-CS-4004
• Status: Withdrawn
• Phase: Phase 2
• First received: December 15, 2014
• Last updated: January 13, 2015
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2015
• 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 with a fixed dose of GCS-100 3 mg IV push in patients with Chronic Kidney Disease (CKD).

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.

This study will consist of a fixed dose of GCS-100 3mg IV push at least every 30 days for a total of 1 year with a follow-up 4 weeks after the last dose is administered.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 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 GCS-100-CS-4003.

Exclusion Criteria:

1. Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4003.

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 values of:

• Hemoglobin: =9 g/dL

• Total bilirubin: >1.5X the upper limit of normal (ULN)

• 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• GCS-100
3 mg GCS-100 IV push. All doses of study drug will be administered least once monthly for a total of 1 year with a follow-up 4 weeks after the last dose is administered.

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	Determine the safety and tolerability of extended dosing with a fixed dose of GCS-100 3 mg IV push in patients with CKD (side effects)	Evaluate side effects of this therapy when administered for an extended period of time. Determine response to therapy (by measuring kidney function monthly) as compared to subjects' response in study GCS-100-CS-4003. To determine if there are changes in markers (chemicals in the blood) in the blood shown to be related to disease state.	Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period	Yes