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

This study has been terminated.
(Lack of Enrollment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01309659
First received: February 17, 2011
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Anemia
Unexplained Anemia
Drug: iron sucrose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 200 ng/mL

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Improvement in 6 Minute Walk Test Results [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine whether the administration of 1000 mg of IV iron sucrose to older adults with UAE and a serum ferritin between 20 and 100 ng/mL leads to improvement in 6MWT results. The primary endpoint is change in 6MWT distances from baseline to 12 weeks. This will be assessed at baseline then at 6 weeks, 12 weeks, 18 weeks, and 24 weeks. In the wait list control group, measures at 12 weeks prior initiating IV iron are outcomes for the control group and they are also treated as the baseline for IV iron treatment at week 12 where treatment visit 1 coincides with the week 12 visit.


Secondary Outcome Measures:
  • Change in hemoglobin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To assess the efficacy of IV iron sucrose in improving Hb by at least 1 g/dL

  • Frequency of clinical events and reportable events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    All clinical events and reportable events will be tabulated and ordered by decreasing frequency for all subjects by randomized groups as a measure of safety and tolerability of IV iron sucrose in older adults

  • Change in cognitive outcome measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part A and B as measured by seconds per completed circle, and the Cogstate yield 9 test scores that will be used in the analyses of the secondary cognitive outcomes

  • Change in serum ferritin in relation to change in hemoglobin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Correlation between baseline serum ferritin and other measures of iron status (transferrin saturation, soluble transferrin receptor, soluble receptor/log ferritin) and response to IV iron sucrose by assessing the relationship between the baseline iron status and the change in HB from baseline to 12 weeks

  • Change in self reported outcomes measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To quantify the impact of anemia treatment by IV iron sucrose on self-reported outcomes measures by change in SF36 8 scale scores and the physical component score and FACIT-AN 5 subscale scores, a trial outcome index and a total score

  • Change in frailty index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty index as measured by change in self-reported exhaustion score, self-reported activity level score, Grip-strength (kgs) and 4 meter walk speed (meters/sec)


Enrollment: 19
Study Start Date: May 2011
Estimated Study Completion Date: April 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Intervention Group
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
Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.
Other Name: Venofer®
Experimental: Wait List Control
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
Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.
Other Name: Venofer®

Detailed Description:

There is a tremendous morbidity and mortality associated with anemia in the elderly and the increasing proportion of elderly adults underscores the population's attributable risk of anemia. As a potentially modifiable factor, an urgent need exists to delineate the impact of anemia correction in the elderly. The Partnership for Anemia: Clinical and Translational Trials in the Elderly (PACTTE) consortium has been created to focus on treatment strategies for anemia in elderly patients. The data presented in this protocol provides a compelling rationale to evaluate the impact of a well-tolerated IV iron preparation in community dwelling older anemic adults with intermediate serum ferritin values.

Subjects will be 65 years or older adults with unexplained anemia and a serum ferritin between 20 and 200 ng/mL.

Subjects will be randomized on a 1:1 basis to either receive a 5 week course of treatment with intravenous iron immediately or to a waitlist control group who will receive treatment with intravenous iron following a 12 week observation period. Both groups will ultimately receive 200mg of intravenous iron sucrose weekly for 5 weeks to determine if this can lead to improvement in 6 Minute Walk Test results. The primary endpoint is change in 6 Minute Walk Test distances from baseline to 12 weeks. The procedures in this protocol will include the use of outcomes tools that have been selected for their ability to show improvement in quality of life in this patient population. Blood samples will also be collected for analysis both at the local lab (safety tests - eg hemoglobin or Hb) or at a central lab for research purposes.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 65 years old
  • Hb 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

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
  • Distance on baseline 6MWT above the median for age and sex
  • History of unstable angina or myocardial infarction in the past 3 months
  • History of stroke or TIA in 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 (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 gram/dL improvement in Hb since starting oral iron supplementation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309659

Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
University of Illinois, Chicago
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins University Geriatrics Center
Baltimore, Maryland, United States, 21224
United States, Ohio
Case Western Reserve University Medical Center
Cleveland, Ohio, United States, 44106
United States, Virginia
Institute For Advanced Studies in Aging
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Elizabeth Price, MD Stanford University MC
Study Chair: Stanley Schrier, MD Stanford University
Principal Investigator: Andrew Artz, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01309659     History of Changes
Obsolete Identifiers: NCT01413919
Other Study ID Numbers: Pro00028687 (PACTTE_01), U01AG034661
Study First Received: February 17, 2011
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Anemia
Unexplained anemia
elderly
geriatric
older adults
UAE
over 65
iron
pactte
pactee
aging
aged
old
older

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014