A Phase 2 Extension of Study GCS-100-CS-4003

• Status: Withdrawn
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: La Jolla Pharmaceutical Company

Criteria

Inclusion Criteria:

1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent

2. Subject was enrolled in GCS-100-CS-4003.

Exclusion Criteria:

1. Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4003.

2. Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening

3. 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

4. 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.

5. Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator.