Disorder Related to Renal Transplantation Clinical Trial
Official title:
Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients
The investigators analyze the clinical outcome of steroid withdrawal protocol starting at 3 months after kidney transplantation using tacrolimus, Mycophenolate Mofetil (MMF), and basiliximab. This study is an open-label, prospective, controlled clinical trial in a single center. Those patients who fulfill the entry criteria could enter in this prospective controlled trial of steroid withdrawal three months after transplantation.
Those patients who fulfill the entry criteria enter in this prospective controlled trial of
steroid withdrawal starting at three months after transplantation. The entry criteria
include 1) no episode of clinically treated nor biopsy confirmed acute rejection up to
entry; 2) serum creatinine level equal to or less than 2 mg/mL on three separate
measurements; 3) no proteinuria (urine protein less than 1000 mg/24 hours; 4) tacrolimus
trough level > 5 ng/ml without signs of nephrotoxicity; 5) agreement to follow the study
protocol.
For the patients who enter into the protocol, prednisolone would be slowly withdrawn by 2.5
mg in every two weeks until 8 weeks after entering the protocol (5 months
post-transplantation). The patients visit every week, and they are closely monitored with
symptoms and signs, blood cell count, chemistry, and urinalysis.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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