Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038064
Status:
COMPLETED
Last Update Posted:
2008-09-15
First Post:
2002-05-28
Brief Title:
Anemia in Patients With a Non-Myeloid Malignancy
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomized Open-Label Study of Darbepoetin Alfa Novel Erythropoiesis Stimulation Protein NESP and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chemotherapy can often cause anemia in patients with cancer Anemia is a low number of red blood cells The symptoms of anemia may include fatigue dizziness headache chest pain and shortness of breath Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body Use of recombinant human erythropoietin allows the body to produce more red blood cells possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells This medication has not been approved to treat cancer patients with anemia however it has been approved by the FDA to treat chronic renal failure patients with anemia
Detailed Description:
None
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