AnemiaPhase 2NCT00210756
Pharmacokinetic/ Pharmacodynamic Study of Epoetin Alfa (PROCRIT) in Critically Ill Patients.
A Phase 2 study testing epoetin alfa in people with Anemia and Critical Illness, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to describe the pharmacokinetics (PK) of six different dosing regimens of epoetin alfa (PROCRIT®) in anemic critically ill subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Critical Illness
- What is being tested?
- epoetin alfa
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Feb 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill subject admitted to a critical care area with a medical diagnosis, (non-surgical, non-trauma) and without evidence of acute blood loss
- or Critically ill subject who develops a medical diagnosis after surgery or trauma and who has no evidence of active bleeding within the prior week and no current transfusion needs
- Expected hospital stay of >= 7 days beyond study entry, age >=18 years
- Hb:<=12 g/dL.
Who cannot join
- Primary admitting diagnosis to the critical care area of acute ischemic cardiac disease or ischemic neurological disease (including but not limited to myocardial infarction or unstable angina, transient ischemic attack, cerebrovascular event)
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Iron deficiency (defined as serum ferritin <50 micrograms/L)
- History of untreated chronic B12 or Folate deficiency (e.g. pernicious anemia). Patients with B12 and folate deficiencies being treated currently may enter the study
- Renal failure on dialysis, including continuous renal replacement therapy (CRRT), at the time of enrollment
- Evidence of acute blood loss within 1 week of enrollment or an active diagnosis of acute or chronic blood loss or hemolysis.
About this study
Official title: Comparative Pharmacokinetic and Pharmacodynamic Study of Epoetin Alfa (PROCRIT) in Anemic Critically Ill Patients Randomized to One of Six Dose Regimens for 15 Days
The purpose of this study is to describe the pharmacokinetics (PK) of six different dosing regimens of epoetin alfa (PROCRIT®) in anemic critically ill subjects
Read the detailed description
Currently, the optimal dosing regimen for achieving and maintaining target Hb concentrations in various clinical settings remains incompletely defined. Both IV and SC routes of administration are used in the clinical setting and have been shown to be effective despite different bioavailability and pharmacokinetic profiles. This study is designed to describe the pharmacokinetic and pharmacodynamic profiles of several different epoetin alfa dosing regimens administered by both IV and SC routes in anemic critically ill patients admitted to a critical care area. The dosing regimens selected will be compared among themselves and against the 40,000 IU SC weekly dosing regimen (A) being used in a large registration trial. Specifically, the six dosing regimens were selected to gather PK and PD data about the following questions: 1) Will an early large Cmax, achieved by IV dosing, stimulate more reticulocytosis? (IV vs. SC dosing regimens A vs. B, C vs. D, E vs. F); 2) Do smaller more frequent doses of the same total dose result in the same PD profile? (A vs. C, B vs. D); 3) Does an IV load improve PD response? (E and F vs. C and D); 4) Do large frequent loading doses accumulate? (A vs. E and B vs. F). Results of this study will provide a pharmacokinetic foundation for understanding and potentially maximizing the pharmacodynamic effects of different dosing options in the critically ill patient. In order to maximize subject safety, all dosing will cease when subject's hemoglobin is > 13g/dL. Group A:40 K SC Qw: Days 1,8,15; Group B:40 K IV Qw: Days 1,8,15; Group C:15 K SC QOD: Days 1,3,5,7,9,11,13,15; Group D:15 K IV QOD: Days 1,3,5,7,9,11,13,15; Group E:40 K SC Days 1 and 3, then 15 K SC QOD: Days 5,7,9,11,13,15; Group F: 40 K IV Days 1 and 3, then 15 K SC QOD: Days 5,7,9,11,13,15
- Conditions
- Anemia, Critical Illness
- Being tested
- epoetin alfa
- Keywords
- Anemia, pharmacokinetics, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care,
- Medical subject headings
- Anemia, Critical Illness
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.
The primary objective of this study is to describe the PK profiles of six different dosing regimens of epoetin alfa in anemic critically ill subjects, including regimen A, that is being used in a large registration trial
Secondary outcomes (1)
To determine reticulocyte response (absolute and %) to the six dosing regimens, as well as the Hb, Hct, and RBC count response. Compare the PD profiles of each dosing regimen to dosing regimen A. describe the safety profile of the six dosing regimens.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210756
- Sponsor's protocol ID
- CR004603
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetic and Pharmacodynamic Study of Epoetin Alfa (PROCRIT) in Anemic Critically Ill Patients Randomized to One of Six Dose Regimens for 15 Days
- ClinicalTrials.gov ID
- NCT00210756
- Acronym / sponsor ID
- CR004603
- Conditions
- Anemia, Critical Illness
- Keywords
- Anemia, pharmacokinetics, erythropoetin, Epoetin alfa, erythropoetin recombinant, Critical care, critical illness, intensive care,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Study start
- Feb 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the pharmacokinetics (PK) of six different dosing regimens of epoetin alfa (PROCRIT®) in anemic critically ill subjects
Detailed description
Currently, the optimal dosing regimen for achieving and maintaining target Hb concentrations in various clinical settings remains incompletely defined. Both IV and SC routes of administration are used in the clinical setting and have been shown to be effective despite different bioavailability and pharmacokinetic profiles. This study is designed to describe the pharmacokinetic and pharmacodynamic profiles of several different epoetin alfa dosing regimens administered by both IV and SC routes in anemic critically ill patients admitted to a critical care area. The dosing regimens selected will be compared among themselves and against the 40,000 IU SC weekly dosing regimen (A) being used in a large registration trial. Specifically, the six dosing regimens were selected to gather PK and PD data about the following questions: 1) Will an early large Cmax, achieved by IV dosing, stimulate more reticulocytosis? (IV vs. SC dosing regimens A vs. B, C vs. D, E vs. F); 2) Do smaller more frequent doses of the same total dose result in the same PD profile? (A vs. C, B vs. D); 3) Does an IV load improve PD response? (E and F vs. C and D); 4) Do large frequent loading doses accumulate? (A vs. E and B vs. F). Results of this study will provide a pharmacokinetic foundation for understanding and potentially maximizing the pharmacodynamic effects of different dosing options in the critically ill patient. In order to maximize subject safety, all dosing will cease when subject's hemoglobin is > 13g/dL. Group A:40 K SC Qw: Days 1,8,15; Group B:40 K IV Qw: Days 1,8,15; Group C:15 K SC QOD: Days 1,3,5,7,9,11,13,15; Group D:15 K IV QOD: Days 1,3,5,7,9,11,13,15; Group E:40 K SC Days 1 and 3, then 15 K SC QOD: Days 5,7,9,11,13,15; Group F: 40 K IV Days 1 and 3, then 15 K SC QOD: Days 5,7,9,11,13,15
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Critically ill subject admitted to a critical care area with a medical diagnosis, (non-surgical, non-trauma) and without evidence of acute blood loss
- or Critically ill subject who develops a medical diagnosis after surgery or trauma and who has no evidence of active bleeding within the prior week and no current transfusion needs
- Expected hospital stay of >= 7 days beyond study entry, age >=18 years
- Hb:<=12 g/dL.
Key exclusion criteria (6 listed)
- Primary admitting diagnosis to the critical care area of acute ischemic cardiac disease or ischemic neurological disease (including but not limited to myocardial infarction or unstable angina, transient ischemic attack, cerebrovascular event)
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Iron deficiency (defined as serum ferritin <50 micrograms/L)
- History of untreated chronic B12 or Folate deficiency (e.g. pernicious anemia). Patients with B12 and folate deficiencies being treated currently may enter the study
- Renal failure on dialysis, including continuous renal replacement therapy (CRRT), at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoetin alfa | Drug | – |
Primary outcome
The primary objective of this study is to describe the PK profiles of six different dosing regimens of epoetin alfa in anemic critically ill subjects, including regimen A, that is being used in a large registration trial
1 secondary outcome
To determine reticulocyte response (absolute and %) to the six dosing regimens, as well as the Hb, Hct, and RBC count response. Compare the PD profiles of each dosing regimen to dosing regimen A. describe the safety profile of the six dosing regimens.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Comparative Pharmacokinetic and Pharmacodynamic Study of Epoetin Alfa (PROCRIT) in Anemic Critically Ill Patients Randomized to One of Six Dose Regimens for 15 Days.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epoetin alfa in people with Anemia and Critical Illness, 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 4 inclusion and 6 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this study is to describe the PK profiles of six different dosing regimens of epoetin alfa in anemic critically ill subjects, including regimen A, that is being used in a large registration trial. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.