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Clinical Trial Details

Trial ID: L0102
Source ID: NCT02664493
Associated Drug: Methylprednisolone
Title: The Effect of Steroid Pulse Therapy for the Reduction of Acute Rejection Episode in Subclinical Borderline Changes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Chronic Renal Failure
Interventions: DRUG: Methylprednisolone
Outcome Measures: Primary: The reduction of acute rejection episode during the first year after renal transplantation in the patients who will show subclinical borderline changes at 2-week protocol biopsy., 1 year | Secondary: Persistent subclinical rejection and chronic graft nephropathy at 1 year protocol biopsy, the rejection will be defined according to Banff criteria including borderline rejection. the degree of chronic graft nephropathy will be calculated based on a chronic sum score of the sum of the Banff chronic indices (cg + ci + ct + cv). the persistent subclinical rejection rate and the degree of chronic graft nephropahty according to the groups will be compared., 1 year|The effect of early steroid pulse therapy on the opportunistic infection including bacterial, fungal, and viral infections., infection episodes will be recorded. cytomegalovirus (CMV), BK polyomavirus (BKV), varicella zoster virus (VZV), bacteria, fungus, TB, pneumocystis carinii infection will be included. rate of infection according to groups will be compared., 1 year
Sponsor/Collaborators: Sponsor: Samsung Medical Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 154
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-02
Completion Date: 2020-07
Results First Posted:
Last Update Posted: 2016-04-06
Locations: Samsung medical center, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02664493