A Phase 2 Extension of Study GCS-100-CS-4003
Withdrawn before enrolling · Phase 2
Conditions studied: Chronic Kidney Disease
In brief
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).
Key facts
- Study ID
- NCT02333955
- Run by
- La Jolla Pharmaceutical Company
- People needed
- 0
- Starts
- 2015-01-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2015-01-15
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Southwest Clinical Research Institute, LLC — Tempe, Arizona, United States
- California Institute of Renal Research — La Mesa, California, United States
- Denver Nephrology — Denver, Colorado, United States
- Mountain Kidney and Hypertension Associates, PA — Asheville, North Carolina, United States
- Clinical Advancement Center, PLLC — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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