Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease

• Status: Withdrawn
• Trial end date: 2019-05-15
• Target enrollment: 0
• Participant gender: All

Summary

Interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (End-stage renal disease and Heart fAilure - Anakinra Remodeling Trial) is a Phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, on cardiorespiratory fitness in patients with advanced chronic kidney disease and heart failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Written informed consent

• 18 years or older

• Chronic heart failure

• Left ventricular ejection fraction less than 50%

• C-reactive protein greater than or equal to 2 mg/L

• Maintenance hemodialysis with a biocompatible membrane, acceptable dialysis adequacy (Kt/V > 1.2), and receipt of a stable hemodialysis prescription for at least 4 weeks OR chronic kidney disease stage IV/V (estimated glomerular filtration rate <30 mL/min/1.73m2)

Exclusion Criteria:

• Inability to complete maximal cardiopulmonary exercise testing

• Need for urgent or emergent care

• Recent use of immunosuppressant, anti-inflammatory therapies or active rheumatologic disease

• Allergy to rubber, latex, Escherichia coli or anakinra