Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)
Status and phase
Withdrawn
Phase 2
Conditions
Chronic Kidney Diseases
Heart Failure, Systolic
Renal Disease, End Stage
Treatments
Drug: Anakinra
Details and patient eligibility
About
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.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
N/A
Interventional model
Single Group Assignment
Masking
None (Open label)
0 participants in 1 patient group
Active Treatment
Experimental group
Description:
Anakinra (Kineret)
Treatment:
Drug: Anakinra
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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