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

NCT03057028 | Completed Phase 1

• 1 other identifier: HM20005870
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in exercise capacity, as determined by peak oxygen consumption and ventilatory efficiency on cardiopulmonary exercise testing

  14 days

Secondary Outcomes (6)

• 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

  14 days

• Change in symptoms of heart failure (as assessed by questionnaire with the Duke Activity Status Index and Minnesota Living With Heart Failure Questionnaire).

  14 days

• Correlate between biomarkers (serum high sensitivity C reactive protein, interluekin-6, and NT-pro BNP) and measures of exercise capacity (peak oxygen consumption and ventilatory efficiency on cardiopulmonary exercise testing)

  14 days

Study Arms (1)

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

Anakinra DRUG

Also known as: Kineret

anakinra

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dan Grinnan, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label treatment with Anakinra

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: February 17, 2017
• Study Start: April 1, 2016
• Primary Completion: June 7, 2018
• Study Completion: June 7, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

US (1)