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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GCS-100
Sponsored by
La Jolla Pharmaceutical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 2

Arm Type

Experimental

Experimental

Arm Label

Low Dose GCS-100

High Dose GCS-100

Arm Description

Low dose of GCS-100

GCS-100 High dose

Outcomes

Primary Outcome Measures

Evaluation of Safety
Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values

Secondary Outcome Measures

Full Information

First Posted
April 9, 2014
Last Updated
December 22, 2016
Sponsor
La Jolla Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT02155673
Brief Title
A Phase 2 Extension Study of Study GCS-100-CS-4002
Official Title
A Phase 2 Extension Study of Study GCS-100-CS-4002
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

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 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.

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
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose GCS-100
Arm Type
Experimental
Arm Description
Low dose of GCS-100
Arm Title
High Dose GCS-100
Arm Type
Experimental
Arm Description
GCS-100 High dose
Intervention Type
Drug
Intervention Name(s)
GCS-100
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of Safety
Description
Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values
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 and completed the End of Study (Day 85) of GCS-100-CS-4002 Exclusion Criteria: Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4002 Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≤100 mmHg at screening Subject has clinical laboratory results of: Hemoglobin: ≤9g/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 Study of Study GCS-100-CS-4002

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