Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)

This is an interventional prevention trial for Renal Insufficiency, Chronic focused on measuring Interleukin-1, Endothelium, Vascular, Vascular Stiffness, Oxidative Stress, Inflammation, Endothelial cells Read More

Inclusion Criteria:

• Age 18-80 years
• CKD stage III or IV (eGFR with the 4-variable Modified Diet Renal Disease (MDRD) prediction equation: 15-60 mL/min/1.73m2; stable renal function in the past 3 months)
• An elevated high sensitivity C-reactive protein (hs-CRP) of > 2.0 mg/L and <30 mg/L on at least 2 consecutive weekly determinations
• Urine protein excretion < 5.0 g/24h estimated by a spot urine protein/creatinine ratio
• Ability to provide informed consent

Exclusion Criteria:

• Patients with advanced CKD requiring chronic dialysis
• Active infection (chronic or acute (within 3 months) or antibiotic therapy (w/in 1 mo); history of recurrent infection
• Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
• Expected to undergo living related transplant in next 6 months
• History of severe congestive heart failure (i.e., EF < 35%)
• Hospitalization in the past month
• 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 hsCRP or immune function
• Immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, etanercept, infliximab, adalimumab, anakinra or long-term oral glucocorticoids taken in past 12 months
• Known malignancy
• HIV, active, chronic hepatitis B as evidenced by HBsAg positive and HBsAb negative, or hepatitis C positive
• Woman who are pregnant, nursing or planning to become pregnant
• Body mass index (BMI) >40 kg/m2
• Warfarin use (or other cytochrome P (CYP)450 substrates with a narrow therapeutic index) [ok if do not participate in endothelial cell collection]
• Taking medication(s) that interact with agents administered during experimental sessions (e.g., sildenafil interacts with nitroglycerin)
• Currently receiving or planning to receive live or inactivated vaccines
• Alcohol dependence or abuse
• Subjects at risk for tuberculosis (TB). Specifically, subjects with:
• Current clinical, radiographic or laboratory evidence of active TB at screening or latent TB that has not been previously treated
• A history of active TB within the last 3 years even if it was treated.
• A history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type.
• Therapy for latent TB which has not been completed as per local guidelines.