A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes
Public ClinicalTrials.gov record NCT02312050. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in patients with chronic kidney disease caused by diabetes. The study will enroll approximately 375 patients at multiple centers located in the United States. Study duration is 6 months. Patients will be randomly assigned 1:1:1:1 to treatment with placebo (0.9% Sodium Chloride Injection, USP), 1 mg, 3 mg, or 9 mg GCS-100. All doses of study drug will be administered via intravenous (IV) push injection once weekly for 2 months (8 weeks), then every other week for an additional 4 months (16 weeks).
Study identification
- NCT ID
- NCT02312050
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 375 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2015
- Primary completion
- Aug 31, 2016
- Completion
- Nov 30, 2016
- Last update posted
- May 18, 2015
2015 – 2016
United States locations
- U.S. sites
- 8
- U.S. states
- 5
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Balboa Nephrology Medical Group | Chula Vista | California | 91910 | — |
| Balboa Nephrology Medical Group | El Centro | California | 92243 | — |
| Balboa Nephrology Medical Group | La Jolla | California | 92037 | — |
| California Institute for Renal Research | La Mesa | California | 91942 | — |
| Denver Nephrology | Denver | Colorado | 80230 | — |
| Mountain Kidney & Hypertension | Asheville | North Carolina | 28801 | — |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37408 | — |
| Clinical Advancement Center | San Antonio | Texas | 78215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02312050, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 18, 2015 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02312050 live on ClinicalTrials.gov.