NCT01663103

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a key mechanism contributing to vascular dysfunction (i.e., large elastic artery stiffening and endothelial dysfunction). Inhibiting inflammation improves vascular dysfunction in other populations characterized by chronic inflammation. However, it is currently unknown if reducing inflammation with an interleukin-1 (IL-1) blocker enhances vascular function in CKD patients. Aim 1 will assess the efficacy of IL-1 blocking with rilonacept for treating vascular dysfunction in patients with stage III or IV CKD (estimated glomerular filtration rate 15-60 mL/min/1.73 m2). Aim 2 will determine if blocking IL-1 with rilonacept also reduces inflammation and oxidative stress. These studies could shift clinical practice guidelines by establishing a novel therapy for reducing CVD risk in CKD patients not requiring chronic hemodialysis.

Conditions

• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Rilonacept	12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)
DRUG	Placebo	Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-08-13
• Last updated: 2016-09-12
• Results posted: 2016-09-12

Locations

2 sites across 1 country: United States