Chronic Kidney Disease Clinical Trial
Official title:
A Phase 2 Extension of Study GCS-100-CS-4003
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).
Status | Withdrawn |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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
La Jolla Pharmaceutical Company |
United States,
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 |
Status | Clinical Trial | Phase | |
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