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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01479010
• Other study ID #: HM13729
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 7, 2011
• Last updated: October 9, 2017
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: October 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Anakinra 100 mg subcutaneously daily
Anakinra 100 mg subcutaneously daily

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Interval Change From Baseline in Peak VO2	Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.	28 days
Primary	Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)	VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.	28 days
Secondary	Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)		28 days
Secondary	Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)		28 days
Secondary	Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2		28 days
Secondary	Rate of Adverse Events and Hospitalizations		28 days
Secondary	Total Exercise Time		28 days
Secondary	Oxygen Uptake Efficiency Slope		28 days