Viewing Study NCT01005706



Ignite Creation Date: 2024-05-05 @ 10:00 PM
Last Modification Date: 2024-10-26 @ 10:12 AM
Study NCT ID: NCT01005706
Status: COMPLETED
Last Update Posted: 2016-03-11
First Post: 2009-10-09

Brief Title: Sirolimus Conversions in African-American Renal Transplant Recipients
Sponsor: Medical University of South Carolina
Organization: Medical University of South Carolina

Study Overview

Official Title: A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients
Status: COMPLETED
Status Verified Date: 2014-02
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: This studys focus is to compare the level effectiveness and safety of regimens involving Sirolimus Cellcept and steroid to Prograf Sirolimus and steroid in African-American recipients of kidney transplants
Detailed Description: A major concern in transplantation is finding a successful regimen of medications to lower the potential for the body to reject the newly transplanted organ The regimens in kidney transplantation include tacrolimus sirolimus mycophenolate mofetil and steroids This study will compare the effectiveness and safety of a regimen including Sirolimus Prograf and steroids compared to a regimen including Sirolimus Cellcept and steroids These regimens have already been researched in the Caucasian population and both drug regimens are FDA approved This studys focus is on the effectiveness and safety of these regimens in African-Americans

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
Secondary IDs
Secondary ID Type Domain Link
HR19042 None None None