A Phase 2a Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

The primary objective of this study is to compare the change in estimated glomerular filtration rate (eGFR) from baseline to Week 8 between placebo and GCS-100 treatment. The secondary objective is to determine the safety and tolerability of GCS-100 administered for 8 weeks relative to placebo. In addition, the study will measure the effect of GCS-100 on circulating galectin-3 and other markers of disease activity.

Key facts

Study ID

NCT01843790

Run by

La Jolla Pharmaceutical Company

People needed

120

Starts

2013-06-01

Expected to finish

2014-09-01

Last updated by the study team

2015-09-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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 is ≥18 and ≤75 years of age; patients >75 years old may be included at the request of the investigator and discretion of the Medical Monitor
• Subject has an eGFR of 15 - 44 mL/min/1.73m2 determined using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (see Section 10.1)
• Patients with CKD diagnosis >12 months and stable, in the opinion of the investigator, within the past 3 months
• Subject is willing and able to comply with all protocol requirements
• 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

You may not qualify if…

• Treatment with an experimental (unlicensed) drug within 4 weeks or ≤5 half-lives prior to screening
• 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
• Planned renal replacement therapy of any kind within 6 months of randomization
• Previous solid organ transplant
• Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening
• 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
• Current treatment with immunosuppressive agents, except for topical agents or inhaled steroids when conditions are chronic and stable
• Treatment with any form of IV iron therapy within 4 weeks prior to screening
• Known history of cancer (excluding non-melanoma skin cancer that is not being actively treated) within 5 years of screening
• Known history of human immunodeficiency virus, active hepatitis C virus (HCV), active hepatitis B virus (HBV), or prior history of infection with HBV (HBcAb positive); if adequate hepatic function has been documented for patients with HCV or prior history of hepatitis B without evidence of cirrhosis, the Medical Monitor may approve their enrollment
• 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, severe or uncontrolled chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis.
• Subject had major surgery within 4 weeks of randomization
• If female, subject is pregnant or breastfeeding
• 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

Where it is running

• Southwest Clinical Research Institute, LLC — Tempe, Arizona, United States
• California Institute of Renal Research — La Mesa, California, United States
• Denver Nephrology — Denver, Colorado, United States
• Clinical Advancement Center, PLLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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