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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01506726
• Date of registration: 06/01/2012
• Primary sponsor: Harvey Jay Cohen
• Public title: Trial To Evaluate the Efficacy of Oral Salsalate in the Treatment of Older Adults With Unexplained Anemia
• Scientific title: A Randomized, Double-Blind, Placebo Controlled Pilot Trial of Oral Salsalate in the Treatment of the Subset of Unexplained Anemia in Elderly Patients With Elevated Interleukin-6
• Date of first enrolment: March 2012
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01506726
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Kerstin McHutchison, RN

• Name: William Ershler, MD
• Affiliation: Institute for Advanced Studies in Aging (IASIA)

• Name: Jeremy Walston, MD
• Affiliation: Johns Hopkins University

• Name: Stanley Schrier, MD
• Affiliation: Stanford University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Age 70 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 = 2.5 pg/mL obtained during screening period (performed at central
laboratory).

- Must be able to understand and speak in English

Exclusion Criteria:

- 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

- Total bilirubin > 1.5 mg/dL

- Use of any other experimental drug or therapy within 28 days of initial screening
visit

- History of tinnitus 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 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



Age minimum: 70 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia

Unexplained Anemia

Intervention(s)

Drug: Salsalate

Drug: Salsalate placebo

Primary Outcome(s)

Improvement in hemoglobin level from baseline to 6 month visit [Time Frame: 6 months]

Secondary Outcome(s)

Change in cognitive outcome measures [Time Frame: 6 months]

Change in frailty index [Time Frame: 6 months]

Change in markers of inflammation [Time Frame: 6 months]

Change in self reported outcomes measures [Time Frame: 6 months]

Examination of association between hemoglobin and reduced inflammatory profile [Time Frame: 6 months]

Improvement in 6 minute walk test [Time Frame: 6 months]

Improvement in serum biomarkers of erythropoiesis [Time Frame: 6 months]

Reduction in serum hepcidin levels [Time Frame: 6 months]

Secondary ID(s)

Pro00033852

U01AG034661

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute on Aging (NIA)