Pilot Study of the Safety and Efficacy of Anakinra in Pul... | NCT03057028

Studies
Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension

NCT03057028

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Apr 5, 2019Actual

Enrollment

7Actual

Phase

Phase 1

Conditions

Pulmonary Arterial Hypertension

Interventions

Anakinra

Countries

United States

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Jun 7, 2018Actual

Completion Date

Jun 7, 2018Actual

First Submitted Date

May 4, 2016

First Submission Date that Met QC Criteria

Feb 14, 2017

First Posted Date

Feb 17, 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

Apr 4, 2019

Last Update Posted Date

Apr 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pulmonary arterial hypertension (PAH) can result in right ventricular failure and death. Anakinra has been used in patients with left sided heart failure, and the present study looks to determine if anakinra is safe and effective in patients with PAH. To accomplish this goal, we plan to evaluate for exercise improvement (as assessed by cardiopulmonary exercise testing) in 10 patients with PAH on anakinra.

Detailed Description

Patients with pulmonary arterial hypertension will undergo cardiopulmonary exercise testing (CPET) at baseline and at 2 weeks. After the initial CPET, all patients will receive anakinra as a daily injection for 2 weeks. Patients will be instructed in the use of anakinra during their initial visit. Our primary outcome will be the difference in the exercise capacity of patients with PAH, as measured by maximal uptake of oxygen on CPET.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
anakinra	Experimental	Patients will be treated with anakinra, injected SQ daily in a dose of 100mg for 14 days. Before and after this intervention, patients will undergo cardiopulmonary exercise testing (as well as echocardiography, EKG analysis, and serologic analysis). Subjects will be assessed for changes in exercise capacity, as determined by peak oxygen uptake and ventilatory efficiency to CO2 production slope.	Drug: Anakinra

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anakinra	Drug		anakinra	Kineret

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in exercise capacity, as determined by peak oxygen consumption and ventilatory efficiency on cardiopulmonary exercise testing		14 days

Secondary Outcomes

Measure	Description	Time Frame
Effect of anakinra on serum high sensitivity C-reactive protein		14 days
Effect of anakinra on serum NT-pro-BNP.		14 days
Effect of anakinra on serum interleukin-6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age over 18
functional class II or III symptoms of right ventricular failure despite optimal PAH therapy
mean pulmonary artery pressure >25mmHg on previous right heart catheterization
pulmonary arterial wedge pressure <15mmHg on previous right heart catheterization
pulmonary vascular resistance >3 wood units on previous right heart catheterization

Exclusion Criteria:

PAH due to connective tissue disease
angina or electrocardiograph changes that limit maximum exertion during cardiopulmonary exercise testing or baseline EKG changes that limit the ability to detect ischemia
recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), chronic inflammatory disorder, malignancy, active infection, or any comorbidity limiting survival or ability to complete the study
sever kidney dysfunction (eGFR <30mL/min)
thrombocytopenia (<50,000/mm3), or neutropenia (absolute neutrophil count <1500/mm3)
refusal by a woman of childbearing potential to use a medically acceptable form of birth control
history of hypersensitivity to anakinra or E. coli products
latex or rubber allergy
inability to give informed consent
non-English speaking

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

Name	Affiliation	Role
Dan Grinnan, MD	Virginia Commonwealth University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000081029	Pulmonary Arterial Hypertension

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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

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