Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant
Stopped early · Phase 4
Conditions studied: Transplants and Implants
In brief
The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).
Key facts
- Study ID
- NCT00596947
- Run by
- University of Pennsylvania
- People needed
- 18
- Starts
- 2005-10-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2017-05-15
Who can join
Age: 19 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- First time kidney transplant recipients who receives a kidney from a cadaveric, living related or living unrelated donor
- Age greater than 18 years and less than 75 years
- Caucasian recipients
- Patients with current low panel reactive antibody (PRA) levels (<10%)
- Patients with signed and dated informed consent
- Women of childbearing potential must have a negative pregnancy test at baseline and agree to use a medically acceptable method of contraception throughout the treatment period.
You may not qualify if…
- Other than Caucasian ethnicity
- Patients with HIV+ or
- Patients with HbsAg+ or Hepatitis C positive
- Patients with a history of malignancy in the past 5 years
- Patients with active systemic or localized major infection
- Patients with a history of chronic steroid use for other diseases
Where it is running
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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