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Sponsors and Collaborators: |
Florida Hospital Transplant Center Genzyme Novartis |
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Information provided by: | Florida Hospital Transplant Center |
ClinicalTrials.gov Identifier: | NCT00273559 |
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.
Condition | Intervention | Phase |
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Kidney Diseases |
Drug: prednisone |
Phase IV |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2008 |
Groups/Cohorts | Assigned Interventions |
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1
subjects who remain on steroids after discharge
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2
Subjects will be off steroids at the time of discharge
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Drug: prednisone
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.
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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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
de novo renal transplant recipients
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Florida Hospital Transplant Center | |
Orlando, Florida, United States, 32804 |
Principal Investigator: | Michael Angelis, MD | Florida Hospital Transplant Center |
Responsible Party: | Florida Hospital Transplant Center ( Michael Angelis, MD ) |
Study ID Numbers: | TL092005-1 |
Study First Received: | January 5, 2006 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00273559 |
Health Authority: | United States: Institutional Review Board |
Renal Transplantation |
Prednisone Urologic Diseases Kidney Diseases |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |