Clinical Trial Details
| Trial ID: | L0233 |
| Source ID: | NCT01843790 |
| Associated Drug: | Gcs-100 |
| Title: | A Phase 2a Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: GCS-100|DRUG: Placebo, Saline |
| Outcome Measures: | Primary: Change in estimated glomerular filtration rate (eGFR) from baseline relative to placebo after administration of GCS-100 for 8 weeks in patients with chronic kidney disease (CKD) and baseline eGFR of 15 - 44 mL/min/1.73m2, 12 weeks | Secondary: Number of adverse events as a measure of safety and tolerability of GCS-100 administered for 8 weeks relative to placebo in patients with CKD, 12 weeks |
| Sponsor/Collaborators: | Sponsor: La Jolla Pharmaceutical Company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 120 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT |
| Start Date: | 2013-06 |
| Completion Date: | 2014-09 |
| Results First Posted: | |
| Last Update Posted: | 2015-09-01 |
| 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|Clinical Advancement Center, PLLC, San Antonio, Texas, 78215, United States |
| URL: | https://clinicaltrials.gov/show/NCT01843790 |
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