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

NCT ID: NCT03062176

Last Updated: 2019-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2019-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Treatment

Anakinra (Kineret)

Group Type EXPERIMENTAL

Anakinra

Intervention Type DRUG

Anakinra (Kineret)

Interventions

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Anakinra

Anakinra (Kineret)

Intervention Type DRUG

Other Intervention Names

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Kineret

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin W Van Tassell, PharmD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Other Identifiers

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HM20007618

Identifier Type: -

Identifier Source: org_study_id

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