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

Stopped early · Phase 1/Phase 2

Conditions studied: Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT01479010

Run by

Virginia Commonwealth University

People needed

2

Starts

2011-11-01

Expected to finish

2013-11-01

Last updated by the study team

2017-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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