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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03062176
Collaborator
(none)
0
Enrollment
1
Arm
25.4
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease (E-HART)
Actual Study Start Date :
Apr 3, 2017
Actual Primary Completion Date :
May 15, 2019
Actual Study Completion Date :
May 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active Treatment

Anakinra (Kineret)

Drug: Anakinra
Anakinra (Kineret)
Other Names:
  • Kineret

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak oxygen consumption (PVO2) [6 months]

      Peak oxygen consumption during cardiopulmonary exercise

    Secondary Outcome Measures

    1. Heart Failure Hospitalization [6 months]

      Number of participants with a hospitalization for heart failure during the 6 months of treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Virginia Commonwealth University

    Investigators

    • Principal Investigator: Benjamin W Van Tassell, PharmD, Virginia Commonwealth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT03062176
    Other Study ID Numbers:
    • HM20007618
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    May 17, 2019
    Last Verified:
    May 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Virginia Commonwealth University
    Heart failure
    End-stage renal disease
    Interleukin-1
    Interleukin-1 receptor antagonist
    Metabolomics
    Lipidomics
    Chronic kidney disease
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Kidney Failure, Chronic
    Heart Failure
    Heart Failure, Systolic
    Interleukin 1 Receptor Antagonist Protein

    Study Results

    No Results Posted as of May 17, 2019