Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/20/2018 |
| Start Date: | April 3, 2017 |
| End Date: | November 2019 |
| Contact: | Benjamin W Van Tassell, PharmD |
| Email: | bvantassell@vcu.edu |
| Phone: | (804) 828-4583 |
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)
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.
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.
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
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