Study Stopped
Corporate decision
A Phase 2 Extension of Study GCS-100-CS-4003
1 other identifier
interventional
N/A
1 country
5
Brief Summary
The primary objective of this study is to determine the safety and tolerability of extended dosing with a fixed dose of GCS-100 3 mg IV push in patients with Chronic Kidney Disease (CKD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2015
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJanuary 15, 2015
January 1, 2015
1.5 years
December 15, 2014
January 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
3 mg IV push
EXPERIMENTALGCS-100
Interventions
3 mg GCS-100 IV push. All doses of study drug will be administered least once monthly for a total of 1 year with a follow-up 4 weeks after the last dose is administered.
Eligibility Criteria
You may qualify if:
- Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
- Subject was enrolled in GCS-100-CS-4003.
You may not qualify if:
- Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4003.
- Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening
- Subject has clinical laboratory values of:
- Hemoglobin: ≤9 g/dL
- Total bilirubin: \>1.5X the upper limit of normal (ULN)
- ALT and/or AST: \>2.5X ULN
- Subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk.
- Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
George Tidmarsh, MD, PhD
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2014
First Posted
January 8, 2015
Study Start
January 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
January 15, 2015
Record last verified: 2015-01