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

NCT ID: NCT02155673

Last Updated: 2016-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes. Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney. GCS-100 is a galectin-3 antagonist that has been shown to reduce fibrosis pre-clinically. Based on the role of galectin-3 and fibrosis in kidney disease, the Sponsor believes GCS-100 may be effective at treating patients with CKD.

Study GCS-100-CS-4002 is an ongoing randomized, placebo controlled study of GCS-100 in Stage 3b and 4 CKD. The objective of the study is to determine the safety and efficacy of 8 weekly injections of GCS-100 on eGFR. Patients who have completed that study without adverse safety events, may be asked to participate in this study to test the safety of prolonged administration of study drug.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low Dose GCS-100

Low dose of GCS-100

Group Type EXPERIMENTAL

GCS-100

Intervention Type 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

GCS-100 High dose

Group Type EXPERIMENTAL

GCS-100

Intervention Type 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.

Interventions

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GCS-100

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.

Intervention Type DRUG

Eligibility Criteria

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

Exclusion Criteria

1. Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4002
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 results of:

1. Hemoglobin: ≤9g/dL
2. Total bilirubin: \>1.5X the upper limit of normal (ULN)
3. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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La Jolla Pharmaceutical Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Tidmarsh, MD, PhD

Role: STUDY_DIRECTOR

Locations

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Southwest Clinical Research Institute, LLC

Tempe, Arizona, United States

Site Status

California Institute of Renal Research

La Mesa, California, United States

Site Status

Denver Nephrology

Denver, Colorado, United States

Site Status

Mountain Kidney and Hypertension Associates, PA

Asheville, North Carolina, United States

Site Status

Clinical Advancement Center, PLLC

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GCS-100-CS-4003

Identifier Type: -

Identifier Source: org_study_id