Steroid Withdrawal Immunosuppression After Renal Transplantation
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients|
- the incidence of biopsy-confirmed acute rejection. [ Time Frame: 12 months ] [ Designated as safety issue: No ]The primary efficacy variable was the incidence of biopsy-confirmed acute rejection.
- death, graft loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]The secondary efficacy variables included the cumulative incidence of a composite endpoint of death, and graft loss;
- adverse events and serious adverse events [ Time Frame: 6 months , 12 months ] [ Designated as safety issue: No ]The proportion of successfully steroid-withdrawn and steroid-free population at 6 months and at 12 months post-transplantation as well as the safety variables including the incidence of adverse events and serious adverse events, [blood pressure, lipid levels (total cholesterol), BUN (blood urea nitrogen) and blood glucose levels]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||July 2012|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
No Intervention: steroid withdrawal
The clinical outcome after kidney transplantation, under the immunosuppression of steroid withdrawal starting at 3 months post-transplantation using tacrolimus, mycophenolate mofetil, and basilixumab should be analyzed.
Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550445
|Contact: chang-kwon Oh, M.Dfirstname.lastname@example.org|
|Korea, Republic of|
|Ajou University Hospital||Recruiting|
|Suwon, Korea, Republic of, 443-749|
|Contact: chang-kwon oh, M.D. 82-10-91657281 OHCK@ajou.ac.kr|
|Principal Investigator: chang kwon oh, M.D|
|Principal Investigator:||Chang kwon oh, M.D.,Ph. D.||Department of surgery, Ajou University School of Medicine|