Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091910
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2004-09-19
Brief Title:
Research Into the Treatment of Anemia for Critically Ill Patients Admitted to Intensive Care Units ICU
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Determine the Efficacy and Safety of Epoetin Alfa in Critically Ill Subjects
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Erythropoietin EPO is a hormone produced in the kidney Its function is to stimulate the production of red cells in the bone marrow The purpose of this research study is to demonstrate that the administration EPO to critically ill subjects in the intensive care unit ICU reduces the number of patients requiring red blood cell RBC transfusion as compared with placebo a liquid without active medicine
Detailed Description:
In this study the amount of drug and frequency of dosing is under investigation Erythropoietin EPO will be given by subcutaneous injection a small needle prick placed underneath the skin The maximum number of injections a patient may receive is 3 The total expected length of time of patient participation in the study is about 140 days about 5months
This study consists of a screening period treatment period and post treatment period The study doctor will determine whether the patient is suitable for the study Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests vital signs such as blood pressure physical examinations and the occurrence and severity of adverse events as well as other study specific procedures
Eligible patients will be assigned by chance like flipping a coin to one of two treatment groups 40000 units of EPO or Placebo Unless the need arises neither the patient nor the study staff will know which treatment the patient receives
The patient will receive an injection of study drug on Study Days 1 8 and 15 as long as they remain in the same hospital and their hemoglobin Hb level is less than 12gdL If the patients hemoglobin level is greater than 12gdL on any scheduled medication day study medication will not be given However the patient will remain in the study and a re-assessment will be done at the next dosing time point The patient will also receive iron therapy at least 150 mg from Study Day 1 if tolerated through Study Day 29 or until the patient is discharge from the hospital or withdraws from the study whichever comes first
Treatment with study drug will be stopped if the patient become pregnant or the study doctor feels that it is in the patients best interest If treatment is stopped before Study Day 15 the patient will be required to return for scheduled study assessments through Study Day 140
The purpose of the post-treatment period is to monitor the patients health status Whether or not the patient remains hospitalized the patient will have two more visits to monitor their health on Study Day 42 and 140 In addition the study doctor and nurse will contact the patient or their caregiver by phone monthly following the Study Day 29 visit until Study Day 140 Weekly subcutaneous injections under the skin of 40000 units of EPO or placebo on days 1 8 and 15
This study consists of a screening period treatment period and post treatment period The study doctor will determine whether the patient is suitable for the study Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests vital signs such as blood pressure physical examinations and the occurrence and severity of adverse events as well as other study specific procedures
Eligible patients will be assigned by chance like flipping a coin to one of two treatment groups 40000 units of EPO or Placebo Unless the need arises neither the patient nor the study staff will know which treatment the patient receives
The patient will receive an injection of study drug on Study Days 1 8 and 15 as long as they remain in the same hospital and their hemoglobin Hb level is less than 12gdL If the patients hemoglobin level is greater than 12gdL on any scheduled medication day study medication will not be given However the patient will remain in the study and a re-assessment will be done at the next dosing time point The patient will also receive iron therapy at least 150 mg from Study Day 1 if tolerated through Study Day 29 or until the patient is discharge from the hospital or withdraws from the study whichever comes first
Treatment with study drug will be stopped if the patient become pregnant or the study doctor feels that it is in the patients best interest If treatment is stopped before Study Day 15 the patient will be required to return for scheduled study assessments through Study Day 140
The purpose of the post-treatment period is to monitor the patients health status Whether or not the patient remains hospitalized the patient will have two more visits to monitor their health on Study Day 42 and 140 In addition the study doctor and nurse will contact the patient or their caregiver by phone monthly following the Study Day 29 visit until Study Day 140 Weekly subcutaneous injections under the skin of 40000 units of EPO or placebo on days 1 8 and 15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None