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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
| Novartis | INDUSTRY |
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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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | subjects who remain on steroids after discharge | ||
| 2 | Subjects will be off steroids at the time of discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone | Drug | group 2 will remain on 5 mg of prednisone for at least 90 days post transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute rejection | 6 months | |
| Patient and graft survival | 6 months | |
| Incidence of infection | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (health survey) | one year | |
| Incidence of post-transplant diabetes | one year | |
| Incidence of osteopenia/osteoporosis at baseline and one year |
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Inclusion Criteria:
Exclusion Criteria:
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de novo renal transplant recipients
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| Name | Affiliation | Role |
|---|---|---|
| Michael Angelis, MD | Florida Hospital Transplant Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Transplant Center | Orlando | Florida | 32804 | United States |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| one year |
| Renal function | one year |
| D052801 | Male Urogenital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |