A Study of Patients With Chronic Kidney Disease to Assess the Safety of a Single Dose of COR-001

Launched by UNIVERSITY OF COLORADO, DENVER · Apr 21, 2017

Keywords

ClinConnect Summary

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo administered subcutaneously to patients with moderate-to-severe chronic kidney disease (CKD) and persistent inflammation (defined as a persistently elevated serum CRP (C-Reactive Protein) level). The primary objective is to evaluate the safety of a single dose of the study drug delivered subcutaneously. Four CKD patients will be randomized to the study drug or placebo within each dosing cohort in a ratio of ...

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Eligibility criteria

• Inclusion Criteria:
• • 1. CKD stage III or IV
• • 2. Serum CRP \> 2 mg/L measured twice during the Screening period at least one week apart
• • 3. Urine protein excretion \< 3.5 g/24h estimated by a spot urine protein/creatinine ratio
• • 4. The patient agrees to comply with the contraception and reproduction restrictions of the study - use 2 forms of acceptable contraception
• Exclusion Criteria:
• • 1. Patients with advanced CKD requiring chronic dialysis
• • 2. Hospitalization over the period of 6 weeks prior to randomization
• • 3. Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs anytime during the study Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary.
• • 4. History of or expected to undergo living related kidney transplant during the study period
• • 5. Currently receiving or planning to receive live or inactivated vaccines
• • 6. Clinical evidence or suspicion of active or smoldering infection (e.g., diabetic foot ulcer) or use of antibiotics during the Screening period
• • 7. History of a positive PPD or prior diagnosis of tuberculosis
• • 8. Evidence of HIV infection or carrier state by serology at Screening
• • 9. Hepatitis B or C by serology (i.e. Hepatitis B Surface Antigen or Hepatitis C antibody positive) at Screening
• • 10. AST or ALT \> 2.5x ULN at Screening
• • 11. History of liver cirrhosis or home oxygen use
• • 12. History of gastrointestinal ulceration or active diverticulitis in the 1 year prior to Screening
• • 13. Absolute neutrophil count \< 2 x 109/L at Screening
• • 14. Platelet count \< 100 x 109/L at Screening
• • 15. Participated in an investigational drug study within 30 days of Screening or Screening is within 5 half-lives of the investigational compound.
• • 16. Known allergy to the study drug or any of its ingredients
• • 17. Breastfeeding or a positive pregnancy test at Screening or Day -1.
• • 18. Any condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would in the opinion of the Investigator increase the risk of the subject's participation in the study.
• • This would include but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy, anemia attributable to a primary hematologic disease (e.g., sickle cell anemia), or any unexplained blackouts.
• • 19. Actively treated malignancy (other than non-melanoma skin cancers) during the 1 year prior to Screening. Patients receiving hormonal treatment only during this period only may be enrolled with the approval of the medical monitor.
• • 20. Myocardial infarction during the 3 months prior to Screening or during Screening
• • 21. Severe arthritis, lupus, inflammatory bowel disease, asthma or other disease(s) or medical condition(s) that, in the opinion of the investigator, could interfere with hs-CRP or immune function
• • 22. Use of CYP substrates with a narrow therapeutic index (please see detailed table below).