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Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension

This study has been terminated.
(recruitment issues, critical investigators left institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01479010
First Posted: November 24, 2011
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
This is an open-label non-randomized, pilot study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with pulmonary hypertension. Subjects will undergo cardiopulmonary exercise testing at baseline, and after 4 weeks treatment with Anakinra (recombinant human Interleukin-1 receptor antagonist.

Condition Intervention Phase
Pulmonary Hypertension Drug: Anakinra 100 mg subcutaneously daily Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Median Interval Change From Baseline in Peak VO2 [ Time Frame: 28 days ]
    Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.

  • Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) [ Time Frame: 28 days ]
    VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.


Secondary Outcome Measures:
  • Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide) [ Time Frame: 28 days ]
  • Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI) [ Time Frame: 28 days ]
  • Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2 [ Time Frame: 28 days ]
  • Rate of Adverse Events and Hospitalizations [ Time Frame: 28 days ]
  • Total Exercise Time [ Time Frame: 28 days ]
  • Oxygen Uptake Efficiency Slope [ Time Frame: 28 days ]

Enrollment: 2
Study Start Date: November 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anakinra Drug: Anakinra 100 mg subcutaneously daily
Anakinra 100 mg subcutaneously daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Diagnosis of PAH (from prior right heart catheterization), with functional class III symptoms of right ventricle failure despite optimal PAH therapy
  • Mean pulmonary artery pressure >25 mmHg
  • Pulmonary capillary wedge pressure <15 mmHg
  • Pulmonary vascular resistance >3 wood units

Exclusion Criteria:

  • PAH due to connective tissue disease (including scleroderma), interstitial lung disease (total lung capacity <65% predicted value), or cirrhosis (portopulmonary hypertension)
  • Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing or baseline ECG changes that limit the ability to detect ischemia (i.e. left bundle-branch block).
  • Recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, active infection, or any comorbidity limiting survival or ability to complete the study
  • Severe kidney dysfunction (eGFR <30 mL/min)
  • Thrombocytopenia (<50,000/mm3), or neutropenia (absolute neutrophil count <1,500/mm3)
  • Refusal by a woman of childbearing potential (not post-menopausal or surgically sterile) to use a medically acceptable form of birth control (including, but not limited to, a diaphragm, an intrauterine device (IUD), progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom) throughout the duration of the study
  • History of hypersensitivity to anakinra or E. coli products
  • Latex or rubber allergy
  • Inability to give informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479010


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Benjamin Van Tassell, Pharm D. Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01479010     History of Changes
Other Study ID Numbers: HM13729
First Submitted: November 7, 2011
First Posted: November 24, 2011
Results First Submitted: May 20, 2015
Results First Posted: June 8, 2015
Last Update Posted: November 10, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents