NCT01506726

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 26, 2015

Completed
Last Updated

October 18, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

January 6, 2012

Results QC Date

October 26, 2015

Last Update Submit

August 31, 2016

Conditions

Anemia

Keywords

anemiaunexplained anemiaelderlygeriatricolder adultsUAEover 65salsalatePACTTEpacteeagingagedoldolder

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin Level From Baseline to 6 Month Visit

    To test whether the administration of oral salsalate to a subset of elderly subjects with unexplained anemia (UAE) and high interleukin (IL-6) levels will improve hemoglobin level

    baseline; 6 months

Secondary Outcomes (15)

  • Change in Markers of Inflammation

    prior to study drug; 6 months

  • Assessment of Serum Biomarkers of Erthropoiesis

    prior to study drug; 6 months

  • Change in Serum Hepcidin Levels

    prior to study drug; 6 months

  • Change in Cognitive Outcome Measures-Trail Making Test Part B

    baseline; 6 months

  • Change in Frailty Component Related to Fatigue/ Exhaustion

    baseline; 6 months

  • +10 more secondary outcomes

Other Outcomes (2)

  • Change in the 6 Minute Walk Test (6MWT) Distance.

    baseline; 6 months

  • Association Between Change in Hemoglobin and Change in Markers of Inflammation.

    prior to study drug; 6 months

Study Arms (2)

Active drug - oral salsalate

EXPERIMENTAL

Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.

Drug: Salsalate

Placebo Arm

PLACEBO COMPARATOR

Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.

Drug: Placebo

Interventions

SalsalateDRUG

Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)

Also known as: salicylate, salicylate acid
Active drug - oral salsalate
PlaceboDRUG

Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months

Also known as: Placebo tablet
Placebo Arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Lakeview Medical Research

Summerfield, Florida, 34491, United States

Location

St Joseph's/Candler Health System

Savannah, Georgia, 31405, United States

Location

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Johns Hopkins University Geriatrics Center

Baltimore, Maryland, 21224, United States

Location

Case Western Reserve University Medical Center

Cleveland, Ohio, 44106, United States

Location

Clinical Research Solutions

Columbia, Tennessee, 38401, United States

Location

Clinical Research Solutions

Franklin, Tennessee, 37064, United States

Location

Clinical Research Solutions

Smyrna, Tennessee, 37167, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

Institute for Advanced Studies in Aging (IASIA)

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

salicylsalicylic acidSalicylates

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

HydroxybenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Results Point of Contact

Title
Harvey J. Cohen, MD
Organization
Duke University Medical Center
harvey.cohen@dm.duke.edu
919-660-7502

Study Officials

  • William Ershler, MD

    Institute for Advanced Studies in Aging (IASIA)

    PRINCIPAL INVESTIGATOR

  • Stanley Schrier, MD

    Stanford University

    STUDY CHAIR

  • Jeremy Walston, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Professor and Chair

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 10, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

October 18, 2016

Results First Posted

November 26, 2015

Record last verified: 2016-08

Locations

US(12)