Trial To Evaluate the Efficacy of Oral Salsalate in the Treatment of Older Adults With Unexplained Anemia

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Anemia

In brief

The purpose of this study is to determine whether treatment of unexplained anemia in older adults and elevated inflammatory markers with oral salsalate can improve hemoglobin levels and improve physical activity and quality of life.

Key facts

Study ID

NCT01506726

Run by

Harvey Jay Cohen

People needed

11

Starts

2012-03-01

Expected to finish

2014-11-01

Last updated by the study team

2016-10-18

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Understand and voluntarily sign an informed consent form
• Age 65 years and older, residing in the community or in an assisted-living facility
• Able to adhere to the study visit schedule and other protocol requirements
• Hemoglobin concentration ≥ 9.0 g/dL and < 11.5 g/dL for women and ≥ 9.0 to < 12.7 g/dL for men
• Unexplained anemia (See Appendix 2 for definitions of anemia diagnosis to determine anemia is unexplained)
• Serum IL-6 level ≥ 1.0 pg/mL obtained during screening period (performed at central laboratory).
• Must be able to understand and speak in English; or Spanish speaking subjects who do not speak English may be enrolled per local IRB process and approval, provided the site has appropriate bilingual study staff.

You may not qualify if…

• Red blood cell transfusions within the past 3 months
• Estimated glomerular filtration rate (eGFR) of < 30 ml/min (by abbreviated MDRD)
• Use of erythropoiesis stimulating agents (ESA) in the past 3 months
• Active infection defined as symptomatic, requiring active treatment (prophylaxis allowed) or hospitalized for > 24 hours primarily for infection within the past month
• Uncontrolled hypertension defined as diastolic blood pressure > 95 mm Hg or systolic blood pressure > 160 mm Hg on 2 separate occasions during screening period
• Distance on 6MWT above the median for age and sex adjusted population medians (see Table 4)
• Other primary uncorrected cause for anemia including:
• Known active inflammatory disease including auto-immune diseases (e.g., systemic lupus erythematosis, rheumatoid arthritis, mixed connective tissue disease, sarcoidosis, bronchiolitis obliterans, vasculitis, polymyalgia rheumatica, temporal arteritis, inflammatory bowel disease or related diseases);
• Chronic active infection (e.g., HIV, viral hepatitis, tuberculosis, osteomyelitis) or receiving therapy within the past 3 months for chronic infection
• Acute infection within past 3 months (pneumonia, sepsis, bacteremia, prostatitis, urosepsis, pyelonephritis, cholecystitis)
• Receipt of immunosuppressive therapy in the past 2 years including prednisone except for topical therapy
• 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.
• 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
• Elevated AST or ALT ≥ 2x upper limit of normal
• Use of any other experimental drug or therapy within 28 days of initial screening visit
• History of moderate tinnitus affecting instrumental activities of daily activities in the past 3 months
• 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.
• Elevated thyroid stimulating hormone (TSH), or other signs of hypothyroid condition. Patients on a stable dose of thyroid replacement are eligible, providing TSH is not elevated.
• Seizure disorder for which phenytoin is used for treatment.
• Hypersensitivity to salsalate, salicylic acid, or acetylsalicylic acid
• 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
• Dementia defined as the inability to independently provide informed consent and a Montreal Cognitive Assessment (MoCA) score < 22

Where it is running

• Lakeview Medical Research — Summerfield, Florida, United States
• St Joseph's/Candler Health System — Savannah, Georgia, United States
• University of Illinois, Chicago — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Central Kentucky Research Associates — Lexington, Kentucky, United States
• Johns Hopkins University Geriatrics Center — Baltimore, Maryland, United States
• Case Western Reserve University Medical Center — Cleveland, Ohio, United States
• Clinical Research Solutions — Columbia, Tennessee, United States
• Clinical Research Solutions — Franklin, Tennessee, United States
• Clinical Research Solutions — Smyrna, Tennessee, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States
• Institute for Advanced Studies in Aging (IASIA) — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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