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

Phase 2

Withdrawn

• Conditions: Renal Disease, End Stage; Heart Failure, Systolic; Chronic Kidney Diseases
• Interventions: Drug: Anakinra

• Registration Number: NCT03062176
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2017-04-03
• Status Verified: 2019-05
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Treatment	Anakinra	Anakinra (Kineret)

Primary Outcome Measures

Name	Time	Method
Peak oxygen consumption (PVO2)	6 months	Peak oxygen consumption during cardiopulmonary exercise

Secondary Outcome Measures

Name	Time	Method
Heart Failure Hospitalization	6 months	Number of participants with a hospitalization for heart failure during the 6 months of treatment