A Phase 2 Extension Study of Study GCS-100-CS-4002

Completed · 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 of GCS-100 in patients with CKD.

Key facts

Study ID: NCT02155673
Run by: La Jolla Pharmaceutical Company
People needed: 92
Starts: 2014-01-01
Expected to finish: 2016-06-01
Last updated by the study team: 2016-12-26

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 and completed the End of Study (Day 85) of GCS-100-CS-4002

You may not qualify if…

Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4002
Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≤100 mmHg at screening
Subject has clinical laboratory results of:
Hemoglobin: ≤9g/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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