Interleukin-1 Blockade for the Treatment of Heart Failure... | NCT03062176

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

NCT03062176

Sponsor

Virginia Commonwealth University

Status

Withdrawn

Last Update Posted

May 17, 2019Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

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

Interventions

Anakinra

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We screened over 200 patients but were ultimately unable to enroll anyone

Expanded Access Info

Start Date

Apr 3, 2017Actual

Primary Completion Date

May 15, 2019Actual

Completion Date

May 15, 2019Actual

First Submitted Date

Jan 25, 2017

First Submission Date that Met QC Criteria

Feb 20, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2019

Last Update Posted Date

May 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Treatment	Experimental	Anakinra (Kineret)	Drug: Anakinra

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anakinra	Drug	Anakinra (Kineret)	Active Treatment	Kineret

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak oxygen consumption (PVO2)	Peak oxygen consumption during cardiopulmonary exercise	6 months

Secondary Outcomes

Measure	Description	Time Frame
Heart Failure Hospitalization	Number of participants with a hospitalization for heart failure during the 6 months of treatment	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin W Van Tassell, PharmD	Virginia Commonwealth University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054143	Heart Failure, Systolic
D007676	Kidney Failure, Chronic
D051436	Renal Insufficiency, Chronic
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053590	Interleukin 1 Receptor Antagonist Protein

Ancestor Terms

ID	Term
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided