Clinical Trial Details
| Trial ID: | L0344 |
| Source ID: | NCT02333955 |
| Associated Drug: | Gcs-100 |
| Title: | A Phase 2 Extension of Study GCS-100-CS-4003 |
| Acronym: | |
| Status: | WITHDRAWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease |
| Interventions: | DRUG: GCS-100 |
| Outcome Measures: | 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 | |
| Sponsor/Collaborators: | Sponsor: La Jolla Pharmaceutical Company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 0 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2015-01 |
| Completion Date: | 2016-07 |
| Results First Posted: | |
| Last Update Posted: | 2015-01-15 |
| 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/NCT02333955 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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