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

NCT03062176 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: HM20007618
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Heart failure; End-stage renal disease; Interleukin-1; Interleukin-1 receptor antagonist; Metabolomics; Lipidomics; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption (PVO2)

  Peak oxygen consumption during cardiopulmonary exercise

  6 months

Secondary Outcomes (1)

• Heart Failure Hospitalization

  6 months

Study Arms (1)

Active Treatment

EXPERIMENTAL

Anakinra (Kineret)

Drug: Anakinra

Interventions

Anakinra DRUG

Anakinra (Kineret)

Also known as: Kineret

Active Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

MeSH Terms

Conditions

Heart Failure, Systolic; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Heart Failure

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Benjamin W Van Tassell, PharmD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 23, 2017
• Study Start: April 3, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: May 17, 2019

Record last verified: 2019-05