Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273559
Status:
UNKNOWN
Last Update Posted:
2008-05-12
First Post:
2006-01-05
Brief Title:
A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
Sponsor:
Florida Hospital Transplant Center
Organization:
Florida Hospital Transplant Center
Study Overview
Official Title:
A Single Center Open Label Comparative Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs Steroid Therapy After Renal Transplantation
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to compare the risks and benefits of steroid elimination versus steroid therapy in renal transplant patients particularly looking at the effects on bone mass lipids hypertension and new onset diabetes
Detailed Description:
The use of steroids after renal transplantation has been invaluable resulting in higher rates of long term survival of the transplanted kidney However post-operative steroids are also associated with frequent post-operative and long term complications There have been steroid elimination studies analyzing acute rejection rates graft and patient survival These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids
With this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids We hope to show a decreased rate of complications such as osteopeniaosteoporosis new onset diabetes and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension
Solumedrol will be given to all patients at the time of transplant followed by a prednisone taper Those remaining on steroids will be discharged on prednisone 5 mg daily Those in whom steroids are eliminated will be off prednisone by discharge
With this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids We hope to show a decreased rate of complications such as osteopeniaosteoporosis new onset diabetes and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension
Solumedrol will be given to all patients at the time of transplant followed by a prednisone taper Those remaining on steroids will be discharged on prednisone 5 mg daily Those in whom steroids are eliminated will be off prednisone by discharge
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