A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
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|ClinicalTrials.gov Identifier: NCT00273559|
Recruitment Status : Unknown
Verified November 2007 by Florida Hospital Transplant Center.
Recruitment status was: Active, not recruiting
First Posted : January 9, 2006
Last Update Posted : May 12, 2008
|Condition or disease||Intervention/treatment||Phase|
|Kidney Diseases||Drug: prednisone||Phase 4|
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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||January 2006|
|Estimated Study Completion Date :||December 2008|
subjects who remain on steroids after discharge
Subjects will be off steroids at the time of discharge
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.
- Acute rejection [ Time Frame: 6 months ]
- Patient and graft survival [ Time Frame: 6 months ]
- Incidence of infection [ Time Frame: one year ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273559
|United States, Florida|
|Florida Hospital Transplant Center|
|Orlando, Florida, United States, 32804|
|Principal Investigator:||Michael Angelis, MD||Florida Hospital Transplant Center|