Kidney Diseases Clinical Trial
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
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.
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These studies show that many patients can safely have steroids withdrawn with equivalent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.
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Observational Model: Case Control, Time Perspective: Prospective
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