Clinical Trials

A Randomized, Open-Label, Wait-list Control Trial to Evaluate the Efficacy of Intravenous Iron in Older Adults with Unexplained Anemia and a Serum Ferritin between 20 and 100 ng/mL

Description

Status: Open to Enrollment

Start Date: Jun 22 2011

End Date: Feb 14 2013

This is a Randomized, Open-Label, Wait-list Control Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults with Unexplained Anemia and a Serum Ferritin Between 20 and 100 ng/mL

Objective

To determine whether the administration of 1000 mg of intravenous iron sucrose to older adults with unexplained anemia and a serum ferritin between 20 and 100 ng/mL leads to improvement in 6MWT results.

Participant Eligibility

Inclusion Criteria:
  • Age ≥ 65 years old
  • Hb concentration ≥ 9.0 g/dL and < 11.5 g/dL for women and ≥ 9.0 to < 12.7 g/dL for men
  • Unexplained anemia
  • Serum ferritin level ≥ 20 and ≤ 100 ng/mL
  • Able to walk without the use of a walker, motorized device or the assistance of another person.
  • Must be able to understand and be willing to provide written informed consent in the absence of dementia, defined as a Montreal Cognitive Assessment (MoCA) score ≥ 22
  • Must be able to understand and speak in English
Exclusion Criteria:
  • Red blood cell transfusions within the past 3 months
  • Use of erythropoiesis stimulating agents (ESA) in the past 3 months
  • Intravenous Iron Infusions within the past 3 months
  • History of unstable angina or myocardial infarction in the past 3 months
  • Distance on 6MWT above the median for age and sex adjusted population medians
  • History of stroke or transient ischemic attacks in the past 3 months
  • Uncontrolled hypertension defined as greater than the average diastolic blood pressure > 100 mm Hg or systolic blood pressure > 160 mm Hg on 2 separate occasions on 2 separate days during screening.
  • Positive fecal occult blood test within the screening period
  • Elevated AST (SGOT) or ALT (SGPT) ≥ 2x upper limit of normal
  • Documented anaphylactic reaction to iron sucrose infusion in the past
  • Subjects initiated on oral iron supplementation within the last 6 weeks, or those initiated on oral iron within the last 3 months who have had at least a one g/dL improvement in Hb since starting oral iron supplementation

Subjects will be excluded if they cannot demonstrate decision-making capacity sufficient to agree or decline the blood draw or use of their blood in the study.

Principal Investigators

Neeraj Agarwal, MD

Contact Information

Name: Kim Hickman
Phone: 801-581-3707
Email: kimberly.hickman@hsc.utah.edu

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