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A Phase 2 Extension of Study GCS-100-CS-4003 | Clinical Trials | Clareo Health

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WITHDRAWNPhase 2NCT02333955

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

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).

Lead sponsor: La Jolla Pharmaceutical Company•5 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

La Jolla Pharmaceutical Company

Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes (de Boer et. al., 2011, Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney (Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). 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. This study will consist of a fixed dose of GCS-100 3mg IV push at least every 30 days for a total of 1 year with a follow-up 4 weeks after the last dose is administered.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 15, 2015Terms

Trial snapshot

StatusWITHDRAWN

PhasePHASE2

Enrollment—

Start dateJan 2015

Last updatedJan 15, 2015

Condition

Chronic Kidney Disease

Locations shown

Southwest Clinical Research Institute, LLC

Tempe, Arizona

California Institute of Renal Research

La Mesa, California

Denver Nephrology

Denver, Colorado

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2015Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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