Status:
UNKNOWN
A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
Lead Sponsor:
Florida Hospital Transplant Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
Novartis
Conditions:
Kidney Diseases
Eligibility:
All Genders
18+ years
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, hype...
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 wi...
Eligibility Criteria
Inclusion
- Patients undergoing a single renal transplant from deceased or living donor
- Adults 18 years and older
- First or second renal transplant
- Capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
- Women of child bearing age should have a negative serum pregnancy test
Exclusion
- Greater than 2 renal transplants
- Age \< 18 years
- Patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
- Cold ischemia time \> 30 hours
- History of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
- HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) positive serology
- Loss of previous transplant in \< 1 year
- History of non-compliance
- Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures
- Multiple organ transplant
- History of chronic steroid use except for inhaled steroids for asthma
- Pregnant or lactating females
- Women of childbearing potential not willing to use a reliable form of contraception.
- Patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
- Known sensitivity to study drugs or class of study drugs
- Use of any investigational agent in the last 30 days
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00273559
Start Date
January 1 2006
End Date
December 1 2008
Last Update
May 12 2008
Active Locations (1)
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1
Florida Hospital Transplant Center
Orlando, Florida, United States, 32804