Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338468
Status:
TERMINATED
Last Update Posted:
2011-05-19
First Post:
2006-06-16
Brief Title:
A Study to Assess Disability in Anemic Elderly Patients With Kidney Disease Receiving PROCRIT Epoetin Alfa
Sponsor:
Ortho Biotech Products LP
Organization:
Ortho Biotech Products LP
Study Overview
Official Title:
An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients With Chronic Kidney Disease Receiving PROCRIT Epoetin Alfa
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped early due to slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess disability in anemic patients over the age of 65 who have kidney disease and are receiving weekly PROCRITÂ Epoetin Alfa a glycoprotein that stimulates red blood cell production
Detailed Description:
This is an open-label study in which PROCRIT Epoetin Alfa will be given on a weekly basis starting at a dose lower than is currently approved by the US FDA because treatment is beginning at a higher hemoglobin than usual There is recent evidence to suggest that problems with disability occur in persons over 65 at higher hemoglobins than previously recognized Currently PROCRIT Epoetin Alfa is prescribed for patients with chronic kidney disease three times a week at a dose of approximately 5000 and 10000 units per injection depending on the patients weight This study is starting with a lower dose because treatment is beginning earlier than it normally would Currently doctors usually do not begin PROCRIT Epoetin Alfa in patients with chronic kidney disease until their hemoglobin is 10 gdL
In this study PROCRIT Epoetin Alfa will be given on a weekly basis starting at 5000 units per injection if hemoglobin is 12 gdL Each week hemoglobin will be checked and if after four weeks of treatment it is 13 gdL the PROCRIT Epoetin Alfa dose will be increased to 10000 Units After another four weeks of treatment if the hemoglobin is 13 gdL PROCRIT Epoetin Alfa will be increased to 20000 units After another four weeks of treatment if the hemoglobin is 13 gdL PROCRIT Epoetin Alfa will be increased once more to a final dose of 40000 units In this study patients will be treated with doses higher than currently approved for patients with chronic kidney disease The primary measures of efficacy will be assessed using two disability tests to measure physical function compared from baseline to Week 5 Week 9 Week 13 Week 17 Early Withdrawal and Week 20Follow-up The first test is called the Short Physical Performance Battery SPP which will test how well someone sits stands and walks The second test is called the Six Minute Walk Test 6MWT which measures how far someone can walk during a six-minute period Normal walking aids are allowed during this test The study will also evaluate hemoglobin levels number of transfusions safety incidence of anti-erythropoietin antibodies Quality of Life and cognitive function a measure of how clearly one is thinking The study hypothesis is that physical function will improve when the hemoglobin level is increased Patients will receive PROCRIT Epoetin Alfa on a weekly basis starting at 5000 units per injection up to a maximum of 40000 units
In this study PROCRIT Epoetin Alfa will be given on a weekly basis starting at 5000 units per injection if hemoglobin is 12 gdL Each week hemoglobin will be checked and if after four weeks of treatment it is 13 gdL the PROCRIT Epoetin Alfa dose will be increased to 10000 Units After another four weeks of treatment if the hemoglobin is 13 gdL PROCRIT Epoetin Alfa will be increased to 20000 units After another four weeks of treatment if the hemoglobin is 13 gdL PROCRIT Epoetin Alfa will be increased once more to a final dose of 40000 units In this study patients will be treated with doses higher than currently approved for patients with chronic kidney disease The primary measures of efficacy will be assessed using two disability tests to measure physical function compared from baseline to Week 5 Week 9 Week 13 Week 17 Early Withdrawal and Week 20Follow-up The first test is called the Short Physical Performance Battery SPP which will test how well someone sits stands and walks The second test is called the Six Minute Walk Test 6MWT which measures how far someone can walk during a six-minute period Normal walking aids are allowed during this test The study will also evaluate hemoglobin levels number of transfusions safety incidence of anti-erythropoietin antibodies Quality of Life and cognitive function a measure of how clearly one is thinking The study hypothesis is that physical function will improve when the hemoglobin level is increased Patients will receive PROCRIT Epoetin Alfa on a weekly basis starting at 5000 units per injection up to a maximum of 40000 units
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