A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes

Exclusion Criteria

• •1. Treatment with an experimental (unlicensed) drug within 4 weeks prior to Screening visit 1.
• •2. Patients who are known to be allergic to citrus or have a history of any allergies associated with hypersensitivity to citrus.
• •3. Patients who have begun new treatment with angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), mineralocorticoid receptor blockers (MRBs), or direct renin inhibitors (DRIs) within the 3 months prior to first dose.
• •4. Kidney disease known to be due to causes other than diabetes.
• •5. Patients diagnosed with acute kidney injury (AKI) within the 3 months prior to first dose.
• •6. Planned renal replacement therapy of any kind within 6 months of first study drug dose.
• •7. Previous solid organ transplant.
• •8. Evidence of persistent, uncontrolled hypertension, i.e., systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg; or evidence of persistent, uncontrolled hypotension, i.e., systolic blood pressure ≤ 90 mmHg and diastolic blood pressure ≤ 40 mmHg at repeated measures during Screening.
• •9. Patients who have Screening clinical laboratory values of:
• •1. Hemoglobin: ≤ 9 g/dL
• •2. Total bilirubin: \> 1.5X the upper limit of normal (ULN)
• •3. ALT and/or AST: \> 2.5X ULN
• •4. HbA1c \> 10.5%
• •10. Concomitant treatment with immunosuppressive agents, except for stable use of topical agents or inhaled steroids.
• •11. Patients who have previously received GCS-100 as part of another clinical trial.
• •12. Known history of cancer (excluding non-melanoma skin cancer that is not being actively treated) within 5 years of Screening.
• •13. 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.
• •14. 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.
• •15. Patient had major surgery within 12 weeks of first study drug dose.
• •16. If female, patient is pregnant or breastfeeding.
• •17. Patient 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 patient at unacceptable risk.