1. Red blood cell transfusions within the past 3 months
2. Estimated glomerular filtration rate (eGFR) of < 30 ml/min (by abbreviated MDRD)
3. Use of erythropoiesis stimulating agents (ESA) in the past 3 months
4. Active infection defined as symptomatic, requiring active treatment (prophylaxis allowed) or hospitalized for > 24 hours primarily for infection within the past month
5. Uncontrolled hypertension defined as diastolic blood pressure > 95 mm Hg or systolic blood pressure > 160 mm Hg on 2 separate occasions during screening period
6. Distance on 6MWT above the median for age and sex adjusted population medians
7. Other primary uncorrected cause for anemia including:
a. Known active inflammatory disease including autoimmune diseases (e.g., systemic lupus erythematosis, rheumatoid arthritis, mixed connective tissue disease, sarcoidoisis, bronchiolitis obliterans, vasculitis, polymyalgia rheumatica, temporal arteritis, inflammatory bowel disease or related diseases);
b. Chronic active infection (e.g., HIV, viral hepatitis, tuberculosis, osteomylelitis) or receiving therapy within the past 3 months for chronic infection
c. Acute infection within past 3 months (pneumonia, sepsis, bacteremia, prostatitis, urosepsis, pyelonephritis, cholecystitis)
d. Receipt of immunosuppressive therapy in the past 2 years including prednisone except for topical therapy
e. Any cancer (aside from non-melanoma skin cancer) in the past 2 years or on therapy for cancer. In addition, prostate cancer will be excluded if patients have metastatic disease, have had prostatectomy within the prior 6 months, have ever received external beam radiation therapy or brachytherapy, or have received androgen deprivation therapy in the prior 24 months. Subjects with a history of any other form of
cancer will likewise be excluded if they have received any radiation or chemotherapy in the prior 24 months.
f. Fecal Occult Blood Test positivity in the past 3 years, Gastrointestinal bleeding in past 3 years and history of peptic ulcer w/ evidence of bleeding
8. Elevated AST or ALT ≥ 2x upper limit of normal
9. Total bilirubin > 1.5 mg/dL
10. Use of any other experimental drug or therapy within 28 days of initial screening visit
11. History of tinnitus in the past 3 months
12. Current use of acetylsalicylic acid (aspirin) in doses greater than 82 mg/day in the past 3 months. Subjects will also be ineligible if they consume or are expected to consume non steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, methotrexate, furosemide or anticoagulants during the course of this study.
13. Elevated TSH, or other signs of hypothyroid condition. Patients on a stable dose of thyroid replacement are eligible, providing TSH is not elevated.
14. Seizure disorder for which phenytoin is used for treatment.
15. Hypersensitivity to salsalate, salicylic acid, or acetylsalicylic acid
16. History of transient ischemic attacks (TIA), cerebral vascular accident, a clinical diagnosis of angina or myocardial infarction, any coronary interventions (PCI, Bypass, Stent placement) within the prior 12 months to reduce the risk of subject requiring aspirin therapy during the trial
17. Dementia defined as the inability to independently provide informed consent and a Montreal Cognitive Assessment