Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0419
Source ID: NCT02312050
Associated Drug: Gcs-100
Title: A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetic Chronic Kidney Disease
Interventions: DRUG: GCS-100|DRUG: Placebo
Outcome Measures: Primary: The change in eGFR from Screening to measurements taken at Week 26, 26 weeks | Secondary: Change in eGFR (as a scored value using 20% cut point) from Screening to Week 26, 26 weeks|Change in eGFR (as a scored value using 30% cut point) from Screening to Week 26, 26 weeks|Incidence of renal replacement therapy (RRT), 26 weeks|Incidence of major cardiac events, 26 weeks
Sponsor/Collaborators: Sponsor: La Jolla Pharmaceutical Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 375
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-03
Completion Date: 2016-12
Results First Posted:
Last Update Posted: 2015-05-19
Locations: Balboa Nephrology Medical Group, Chula Vista, California, 91910, United States|Balboa Nephrology Medical Group, El Centro, California, 92243, United States|Balboa Nephrology Medical Group, La Jolla, California, 92037, United States|California Institute for Renal Research, La Mesa, California, 91942, United States|Denver Nephrology, Denver, Colorado, 80230, United States|Mountain Kidney & Hypertension, Asheville, North Carolina, 28801, United States|Southeast Renal Research Institute, Chattanooga, Tennessee, 37408, United States|Clinical Advancement Center, San Antonio, Texas, 78215, United States
URL: https://clinicaltrials.gov/show/NCT02312050

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress