A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Florida Hospital Transplant Center
• Collaborators: Genzyme, a Sanofi Company; Novartis
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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