Clinical Trial Details
| Trial ID: | L0347 |
| Source ID: | NCT02155673 |
| Associated Drug: | Gcs-100 |
| Title: | A Phase 2 Extension Study of Study GCS-100-CS-4002 |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: GCS-100 |
| Outcome Measures: | 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. | |
| Sponsor/Collaborators: | Sponsor: La Jolla Pharmaceutical Company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 92 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT |
| Start Date: | 2014-01 |
| Completion Date: | 2016-06 |
| Results First Posted: | |
| Last Update Posted: | 2016-12-26 |
| Locations: | Southwest Clinical Research Institute, LLC, Tempe, Arizona, 85284, United States|California Institute of Renal Research, La Mesa, California, 91942, United States|Denver Nephrology, Denver, Colorado, 80230, United States|Mountain Kidney and Hypertension Associates, PA, Asheville, North Carolina, 28801, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78215, United States |
| URL: | https://clinicaltrials.gov/show/NCT02155673 |
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