Back to resultsA Phase 2 Extension of Study GCS-100-CS-4003
Primary Purpose
Chronic Kidney Disease
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GCS-100
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
- Subject was enrolled in GCS-100-CS-4003.
Exclusion Criteria:
- Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4003.
- Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening
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
- 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.
- Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator.
Sites / Locations
- Southwest Clinical Research Institute, LLC
- California Institute of Renal Research
- Denver Nephrology
- Mountain Kidney and Hypertension Associates, PA
- Clinical Advancement Center, PLLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3 mg IV push
Arm Description
GCS-100
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02333955
First Posted
December 15, 2014
Last Updated
January 13, 2015
Sponsor
La Jolla Pharmaceutical Company
1. Study Identification
Unique Protocol Identification Number
NCT02333955
Brief Title
A Phase 2 Extension of Study GCS-100-CS-4003
Official Title
A Phase 2 Extension of Study GCS-100-CS-4003
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Corporate decision
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
La Jolla Pharmaceutical Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3 mg IV push
Arm Type
Experimental
Arm Description
GCS-100
Intervention Type
Drug
Intervention Name(s)
GCS-100
Other Intervention Name(s)
MCP (modified citrus pectin)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
Subject was enrolled in GCS-100-CS-4003.
Exclusion Criteria:
Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4003.
Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening
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
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.
Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Tidmarsh, MD, PhD
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Clinical Research Institute, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
California Institute of Renal Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Denver Nephrology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Mountain Kidney and Hypertension Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Extension of Study GCS-100-CS-4003
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