Overview

This trial is active, not recruiting.

Condition kidney diseases
Treatment prednisone
Phase phase 4
Sponsor Florida Hospital Transplant Center
Collaborator Genzyme, a Sanofi Company
Start date January 2006
End date December 2008
Trial size 60 participants
Trial identifier NCT00273559, TL092005-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
subjects who remain on steroids after discharge
Subjects will be off steroids at the time of discharge
prednisone
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.

Primary Outcomes

Measure
Acute rejection
time frame: 6 months
Patient and graft survival
time frame: 6 months
Incidence of infection
time frame: one year

Secondary Outcomes

Measure
Quality of life (health survey)
time frame: one year
Incidence of post-transplant diabetes
time frame: one year
Incidence of osteopenia/osteoporosis at baseline and one year
time frame: one year
Renal function
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Michael Angelis, MD
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 osteopenia/osteoporosis, 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Florida Hospital Transplant Center.