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Safety Study of GCS-100 to Treat Chronic Kidney Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety Study of GCS-100 to Treat Chronic Kidney Disease

A Phase 1 Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease

NCT01717248•La Jolla Pharmaceutical Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic kidney disease.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 is male or female, aged \>=18 and \<= 75. Patients older than 75 y/o will be included at the request of the investigator and at the discretion of the Medical Monitor .
•3\. Adult patients with chronic kidney disease for longer than 12 months and stable in the opinion of the investigator for the past 3 months 4. Systolic blood pressure \<=160 mm Hg and \>= 90 mm Hg on 2 readings. Diastolic blood pressure \<= 100 mm Hg and \>= 40 mm Hg on 2 readings during at least one of the screening visits.
•5\. Subject is willing to practice birth control. 6. Subject is willing and able to comply with all protocol requirements. 7. Subject has a measureable level of galectin-3 concentration in plasma at any time prior to entry.
•8\. Subject has a glomerular filtration rate between 15-45 mL/min/1.73 m2 determined using the CKD-EPI equation (see section 3.6.1) 9. Subject's has clinical laboratory values of:
•1. Hemoglobin ≥9 g/dL
•2. Total bilirubin ≤ 1.5 X Institutional Upper Limit of Normal (IULN)
•3. AST and/or ALT ≤ 2.5 X the upper limit of normal 10. Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least 1 year) and male subjects with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the study period.

Exclusion Criteria

•1. Subjects who have had treatment with an experimental (unlicensed) drug within 4 weeks or ≤ 5 half-lives prior to treatment with GCS 100.
•2. Subjects with kidney disease due to systemic lupus erythematosus (regardless of whether active or in remission), any form of vasculitis (regardless of whether active or in remission), IgA nephropathy, multiple myeloma, polycystic kidney disease, untreated obstructed nephropathy or any other causes that in the opinion of the investigator may put the subject at an increased risk
•3. Subject is expected to start renal replacement therapy of any kind within 6 months after enrollment
•4. Subjects with previous solid organ transplant
•5. Subject is undergoing treatment with immunosuppression agents except for topical agents or inhaled steroids when conditions are chronic and stable.
•6. Subject with know history of cancer within the past 5 years prior to enrollment excluding non-melanoma skin cancer that is not being actively treated
•7. Subject has a known history of human immunodeficiency virus infection, active hepatitis C, active hepatitis B, or prior history of infection with hepatitis B (HBcAb positive). Medical Monitor may approve if adequate hepatic function has been documented for patients without evidence of cirrhosis for subjects with HCV or prior history of hepatitis B, including, but not limited to liver biopsy.
•8. Subject has a clinically relevant active infection and/or a serious co-morbid medical condition such as recent myocardial infarction (within the last 6 months), unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension, difficult-to-control cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis.
•9. Subject had major surgery within 4 weeks prior to Study Day 1.
•10. If female, subject is pregnant or breastfeeding.
+1 more criteria

Locations (4)

Southwest Clinical Research Institute

Tempe, Arizona, United States

California Institue of Renal Research

La Mesa, California, United States

Denver Nephrologists, PC

Denver, Colorado, United States

Renal Associates PA / Research Division

San Antonio, Texas, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

June 20, 2013

Enrollment

ACTUAL participants

Conditions

Chronic Kidney Disease

Interventions

GCS-100

DRUG

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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: June 20, 2013Data synced to Clareo: March 29, 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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Safety Study of GCS-100 to Treat Chronic Kidney Disease

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

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