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

NCT02155673 | Completed Phase 2

• 1 other identifier: GCS-100-CS-4003
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of Safety

  Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values

  Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period.

Study Arms (2)

Low Dose GCS-100

EXPERIMENTAL

Low dose of GCS-100

Drug: GCS-100

High Dose GCS-100

EXPERIMENTAL

GCS-100 High dose

Drug: GCS-100

Interventions

GCS-100 DRUG

1.5 mg/m2 or 30 mg/m2 GCS-100. GCS-100 will be administered as IV infusions once weekly for 8 weeks with a 1 week and 4 week follow-up period and then at least every 30 days for up to a total of 1 year.

High Dose GCS-100; Low Dose GCS-100

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• La Jolla Pharmaceutical Company: lead

Study Sites (5)

Southwest Clinical Research Institute, LLC

Tempe, Arizona, 85284, United States

Location

California Institute of Renal Research

La Mesa, California, 91942, United States

Location

Denver Nephrology

Denver, Colorado, 80230, United States

Location

Mountain Kidney and Hypertension Associates, PA

Asheville, North Carolina, 28801, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

GCS-100

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• George Tidmarsh, MD, PhD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: June 4, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 26, 2016

Record last verified: 2016-12

Locations

US (5)