A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations

Exclusion Criteria

• •PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
• •Chronic thromboembolic or portopulmonary hypertension
• •Total Lung Capacity (TLC) \<60% predicted;
• •FEV1/FVC \<70% predicted or FEV1 \<60% predicted;
• •Evidence of left-sided heart disease;
• •Inability to safely attempt completion of the 6MWD;
• •Life expectancy \<6 months;
• •eGFR \<30 mL/min/1.73 m2 (CKD-EPI equation);
• •Moderate to severe hepatic dysfunction (Child-Pugh score \>10);
• •Serum potassium \>5.1 mEq/L;
• •Use of experimental PAH treatments within the past 3 months;
• •Active infection requiring antibiotic, antifungal, or antiviral therapies;
• •Current systemic treatment with cyclosporine;
• •Known allergy or hypersensitivity to tacrolimus;
• •Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent, follow study protocol, or adhere to study treatment