Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia

NCT01309659 | Terminated Phase 2 Results DMC

• 3 other identifiers: Pro00028687U01AG034661PACTTE_01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to determine whether treatment of unexplained anemia in older adults with a short course of weekly intravenous iron infusions can improve physical activity and therefore quality of life.

Conditions

Anemia; Unexplained Anemia (UAE)

Keywords

Anemia; Unexplained anemia; elderly; geriatric; older adults; UAE; over 65; iron; pactte; pactee; aging; aged; old; older

Outcome Measures

Primary Outcomes (1)

• Change in 6 Minute Walk Test Results

  Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization). The change from baseline to 12 weeks, related to distance, is compared and documented.

  Baseline, 12 weeks

Secondary Outcomes (17)

• Number of Participants Who Had a Hemoglobin Increase >= 1g/dL

  baseline, 12 weeks

• Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B

  Baseline, 12 weeks

• Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)

  Baseline, 12 weeks

• Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)

  baseline, 12 weeks

• Change in Frailty Component Related to Fatigue/ Exhaustion

  baseline, 12 weeks

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.

Drug: iron sucrose

Wait List Control

EXPERIMENTAL

Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up

Drug: iron sucrose

Interventions

iron sucrose DRUG

Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.

Also known as: Venofer®

Immediate Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years old
• Hemoglobin concentration ≥ 9.0 g/dL and \< 11.5 g/dL (women) or \< 12.7 g/dL (men)
• Unexplained anemia
• Serum ferritin level ≥ 20 and ≤ 200 ng/mL
• Able to walk without the use of a walker, motorized device or the assistance of another person.
• Able to understand and willing to provide written informed consent in the absence of dementia
• Must be able to understand and speak in English

You may not qualify if:

• 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
• Distance on baseline 6MWT (6 minute walk test) above the median for age and sex
• History of unstable angina or myocardial infarction in the past 3 months
• History of stroke or TIA (transient ischemic attack) the past 3 months
• Uncontrolled hypertension (diastolic blood pressure \> 100 mm Hg or systolic blood pressure \> 160 mm Hg on 2 separate occasions)
• Positive fecal occult blood test within the screening period
• Elevated AST (aspartate aminotransferase) or ALT (alanine aminotransferase) ≥ 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 gram/dL improvement in Hb since starting oral iron supplementation

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (5)

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, 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

Institute For Advanced Studies in Aging

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Limitations and Caveats

Small sample size.

Results Point of Contact

• Title: Harvey J Cohen, MD
• Organization: Duke University Medical Center

harvey.cohen@dm.duke.edu

919-660-7502

Study Officials

• Elizabeth Price, MD

  Stanford University MC

  PRINCIPAL INVESTIGATOR

• Stanley Schrier, MD

  Stanford University

  STUDY CHAIR

• Andrew Artz, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: March 7, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: September 1, 2014
• Last Updated: February 5, 2016
• Results First Posted: September 8, 2014

Record last verified: 2016-01

Locations

US (5)