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NCT03062176 Clinical Trial

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

Chronic Kidney Diseases Clinical Trial

— E-HART  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03062176
Other study ID # HM20007618
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date April 3, 2017
Est. completion date May 15, 2019

Study information
Verified date May 2019
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 15, 2019
Est. primary completion date May 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Anakinra
Anakinra (Kineret)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Virginia Commonwealth University

Outcome
Type Measure Description Time frame Safety issue
Primary Peak oxygen consumption (PVO2) Peak oxygen consumption during cardiopulmonary exercise 6 months
Secondary Heart Failure Hospitalization Number of participants with a hospitalization for heart failure during the 6 months of treatment 6 months
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