Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00815867
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2008-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Status:
COMPLETED
Status Verified Date:
2016-04
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:
Neo-PDGF
Brief Summary:
Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.
Detailed Description:
French study, prospective, multicenter, open, randomized into two parallel groups:
Group A: NeoRecormon ® 30000 UI: 4 injections Group B: control group without administration of the medical product
Period of recruitment: 18 months Duration of participation of each patient: 90 days Total duration of the test: 21 months.
Main objective : Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant.
Secondary objectives:
Comparing the 2 groups at all times J0 to J90:
* The evolution of renal function
* The survival of patients and grafts
* The time of onset and incidence of acute rejection proved by biopsy
* The correction of anemia
* The need for transfusions
* The need for EPO
* Quality of Life
* The safety processing
Group A: NeoRecormon ® 30000 UI: 4 injections Group B: control group without administration of the medical product
Period of recruitment: 18 months Duration of participation of each patient: 90 days Total duration of the test: 21 months.
Main objective : Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant.
Secondary objectives:
Comparing the 2 groups at all times J0 to J90:
* The evolution of renal function
* The survival of patients and grafts
* The time of onset and incidence of acute rejection proved by biopsy
* The correction of anemia
* The need for transfusions
* The need for EPO
* Quality of Life
* The safety processing
Study Oversight
Has Oversight DMC:
True
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?: