This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction starting at the time of transplant in kidney transplant recipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant.
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant
Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) post transplant. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: As with humoral rejection, there are both acute \& chronic forms: The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections). Class IB: just like Class IA except there is more severe tubulitis. Class IIA: there is mild-to-moderate intimal arteritis. Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area. Class III: there is transmural (e.g. the full vessel wall thickness) arteritis.
Time frame: 3, 6 and 12 months post transplant
Severity of Acute Rejection by Banff '97 Criteria
Severity of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 1 year. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: As with humoral rejection, there are both acute \& chronic forms: The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know: Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections). Class IB: just like Class IA except there is more severe tubulitis. Class IIA: there is mild-to-moderate intimal arteritis. Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area. Class III: there is transmural (e.g. the full vessel wall thickness) arteritis.
Time frame: Severity 1 year post transplant
Difference in Renal Function
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Difference in renal function between groups at listed time points assessed by mean serum creatinine. Increased serum creatinine could indicate worsening renal function. A "normal" serum creatinine range for the transplant population varies by patient, but a typical range for Scr would be 1-2 mg/dL.
Time frame: Difference at 1 month, 3 months, 6 months, 1 year
Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff '97
The Banff features suggestive of chronic rejection were: a) chronic transplant glomerulopathy: Glomerular basement membrane duplication and mesangial cell proliferation, and b) vasculopathy: Fibrous intimal thickening often with fragmentation of internal elastic lamina. Chronic changes in the interstitium (ci), tubules (ct), vessels (cv), and glomerulus (cg) were likewise graded into 0, 1, 2, and 3. The severity of interstitial fibrosis and tubular atrophy, as also chronic transplant glomerulopathy and vasculopathy were used to grade chronic allograft changes.
Time frame: 1 year
Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection
Time frame: 1 year