Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02155673 | A Phase 2 Extension Study of Study GCS-100-CS-4002 | PHASE2 | COMPLETED | 92 | — | — | Jan 1, 2014 | Jun 1, 2016 | Dec 26, 2016 | 5 | United States |
| NCT01843790 | A Phase 2a Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease | PHASE2 | COMPLETED | 120 | — | — | Jun 1, 2013 | Sep 1, 2014 | Sep 1, 2015 | 4 | United States |
| NCT01717248 | Safety Study of GCS-100 to Treat Chronic Kidney Disease | PHASE1 | COMPLETED | 29 | — | — | Jan 1, 2013 | Jun 1, 2013 | Jun 20, 2013 | 4 | United States |
Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values
| Arm | Type | Description |
|---|---|---|
| Low Dose GCS-100 | EXPERIMENTAL | Low dose of GCS-100 |
| High Dose GCS-100 | EXPERIMENTAL | GCS-100 High dose |
| Placebo, saline | PLACEBO_COMPARATOR | Saline, dosed weekly for 8 weeks |
| GCS-100 low dose | EXPERIMENTAL | Low dose of GCS-100 given IV once per week for 8 weeks |
| GCS-100 high dose | EXPERIMENTAL | High dose of GCS-100 given IV once per week for 8 weeks |
| GCS-100 | EXPERIMENTAL | GCS-100 will be administered once weekly by a ten minutes injection. |
| Name | Type | Description |
|---|---|---|
| GCS-100 | DRUG | 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. |
| Placebo, Saline | DRUG | The amount (in mg) of drug to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL. |
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...