A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
Study Details
Study Description
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, hypertension, and new onset diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 subjects who remain on steroids after discharge |
|
| 2 Subjects will be off steroids at the time of discharge |
Drug: prednisone
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.
|
Outcome Measures
Primary Outcome Measures
- Acute rejection [6 months]
- Patient and graft survival [6 months]
- Incidence of infection [one year]
Secondary Outcome Measures
- Quality of life (health survey) [one year]
- Incidence of post-transplant diabetes [one year]
- Incidence of osteopenia/osteoporosis at baseline and one year [one year]
- Renal function [one year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergoing a single renal transplant from deceased or living donor
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Adults 18 years and older
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First or second renal transplant
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Capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
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Women of child bearing age should have a negative serum pregnancy test
Exclusion Criteria:
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Greater than 2 renal transplants
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Age < 18 years
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Patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
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Cold ischemia time > 30 hours
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History of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
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HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) positive serology
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Loss of previous transplant in < 1 year
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History of non-compliance
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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
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Multiple organ transplant
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History of chronic steroid use except for inhaled steroids for asthma
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Pregnant or lactating females
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Women of childbearing potential not willing to use a reliable form of contraception.
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Patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
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Known sensitivity to study drugs or class of study drugs
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Use of any investigational agent in the last 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Hospital Transplant Center | Orlando | Florida | United States | 32804 |
Sponsors and Collaborators
- Florida Hospital Transplant Center
- Genzyme, a Sanofi Company
- Novartis
Investigators
- Principal Investigator: Michael Angelis, MD, Florida Hospital Transplant Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TL092005-1