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AnemiaPhase 2NCT00210795

A Phase II Study to Assess Changes in Physical Function in Elderly Patients With Chronic Anemia

A Phase 2 study testing epoetin alfa in people with Anemia and Aged, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess changes in physical function in elderly patients (>= 65 years of age) with chronic anemia (Hb <= 11.0 g/dL) due to anemia of unknown cause and receiving weekly subcutaneous doses of Epoetin alfa (PROCRIT®) versus placebo Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Anemia, Aged, Hemoglobins
What is being tested?
epoetin alfa
How many people
12 participants
Where
No sites listed yet
Study dates
Jun 2004to Oct 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients with a history of chronic anemia defined as a documented Hb value of <= 11.0 g/dL
  • No active cancer
  • At least 65 years of age with life expectancy of > 6 months
  • Community dwelling patients
  • Patients with a Short Physical Performance (SPPB) Summary Score of 4-10 at screening and baseline
  • Patients with an Mini Mental State Examination (MMSE) score >= 24

Who cannot join

  • Positive stool guaiac test
  • Diagnosis of multiple myeloma and/or MGUS
  • History of venous thromboembolytic disease
  • Previous treatment with Epoetin alfa, Darbepoetin or any form of erythropoietin recently
  • Uncontrolled or severe cardiovascular disease

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Study to Assess Changes in Physical Function in Elderly Patients With Anemia of Chronic Disease (ACD) Receiving Epoetin Alfa (PROCRIT�)

The purpose of this study is to assess changes in physical function in elderly patients (>= 65 years of age) with chronic anemia (Hb <= 11.0 g/dL) due to anemia of unknown cause and receiving weekly subcutaneous doses of Epoetin alfa (PROCRIT®) versus placebo

Read the detailed description

Some elderly patients have a chronic condition that causes anemia (reduction in hemoglobin level, or low red cell count). Anemia occurs commonly with aging and is a frequent medical condition in individuals over the age of 65. Physical performance and function is generally worse in individuals who are anemic. This is a randomized, double-blind, placebo-controlled, multi-center study to assess physical function (to include falls) and fatigue in approximately 80 elderly patients with chronic anemia (anemia present for at least 3 months) and who are receiving weekly PROCRIT. The study will also evaluate hemoglobin levels (oxygen carrying protein in red blood cells), safety, fatigue and cognitive function. The study hypothesis is to demonstrate the study drug will be more effective in treatment of chronic anemia than placebo, resulting in the improvement of physical function and subsequent disabilities, generally well-tolerated. The patients will receive weekly injections of Epoetin alfa (PROCRIT®) or placebo at a starting dose of 10,000 units administered subcutaneously (under the skin).

Conditions
Anemia, Aged, Hemoglobins
Being tested
epoetin alfa
Keywords
Anemia, Subcutaneous injection, PROCRIT, Erythropoietin, Epoetin Alfa, Hemoglobin Level, Elderly
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epoetin alfaDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the change in physical function from baseline to end of study as measured by the Short Physical Performance Battery (SPPB) summary score.

Secondary outcomes (1)

  1. To assess efficacy of PROCRIT by achieving a target Hb of 12.5-12.9 g/dL;Change in FACT-An score;Change in Six-Minute Walk Test,Safety (Adverse Event Incidents, Lab Tests and Vital Signs);Cognitive function; Number and type of injuries from falls

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Study completionOct 2005

Why it stopped: This study was stopped due to slow enrollment after enrolling only 12 of 80 patients over 14 months time.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00210795
Sponsor's protocol ID
CR004627
Status last verified
Apr 2010
First submitted
13 Sep 2005
Last updated
10 Jun 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing epoetin alfa in people with Anemia and Aged, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study was stopped due to slow enrollment after enrolling only 12 of 80 patients over 14 months time.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the change in physical function from baseline to end of study as measured by the Short Physical Performance Battery (SPPB) summary score.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00210795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.

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