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

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status and phase

Withdrawn
Phase 2

Conditions

Chronic Kidney Diseases
Heart Failure, Systolic
Renal Disease, End Stage

Treatments

Drug: Anakinra

Study type

Interventional

Funder types

Other

Identifiers

NCT03062176
HM20007618

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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