Safety Study of GCS-100 to Treat Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT01717248
First received: October 26, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease
Drug: GCS-100
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by La Jolla Pharmaceutical Company:

Primary Outcome Measures:
  • Evaluation of Safety [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
    Assess overall safety of rising dose of GCS-100 in CKD patients


Enrollment: 29
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GCS-100
GCS-100 will be administered once weekly by a ten minutes injection.
Drug: GCS-100
GCS-100 is a modified citrus pectin that binds to and sequesteres circulating galectin-3, a protein that has been shown to promote organ disease (fibrosis).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  11. 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 could put the subject at unacceptable risk.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717248

Locations
United States, Arizona
Southwest Clinical Research Institute
Tempe, Arizona, United States, 85284
United States, California
California Institue of Renal Research
La Mesa, California, United States, 91942
United States, Colorado
Denver Nephrologists, PC
Denver, Colorado, United States, 80230
United States, Texas
Renal Associates PA / Research Division
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
La Jolla Pharmaceutical Company
Investigators
Principal Investigator: Pablo Pergola, MD Renal Associaties PA, Research Division
Principal Investigator: Geoffrey Block, MD Denver Nephrologists, PC
Principal Investigator: Bhupinder Singh, MD Southwest Clinical Research Institute, LLC
Principal Investigator: George Fadda, MD California Institute of Renal Research
  More Information

No publications provided

Responsible Party: La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT01717248     History of Changes
Other Study ID Numbers: GCS-100-CS-4001
Study First Received: October 26, 2012
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 26, 2014