The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.
The development of DSA post-transplant has been associated with chronic rejection and graft failure. EC-MPS is thought to be the key drug preventing both cellular and antibody mediated rejections. Several studies have shown that recipients receiving an optimal dose of EC-MPS have fewer antibody mediated rejections and may require a lower dose of calcineurin inhibitors and/or corticosteroids thus reducing side effects and extending graft survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of EC-MPS is achieved. Maximum dose will not exceed 2160 mg daily.
East Carolina University
Greenville, North Carolina, United States
Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)
Time frame: 24 months
To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.
Time frame: 24 months
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