This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg\*h/L compared to a standard dosing regimen of EC-MPS. Additionally, this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Tablets for oral administration
Novartis Investigational Site
Various Cities, Germany
Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L
Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.
Time frame: Assessed on day 3, 10, 21, 42, 56 and 84
Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment
Median time to first occurrence of treatment failure was not reached in this study.
Time frame: 6 months
Number of Participants With Any Treatment Failure
Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.
Time frame: 6 months
Number of Participants With Single Treatment Failures
Rates for all individual components of the primary endpoint 'treatment failure' until day 180: * Acute rejection diagnosed by biopsy (BPAR) * graft loss * death * loss to follow up * discontinuation from study drug due to lack of efficacy or toxicity (adverse events, every adverse event had to be interpreted as toxicity) * conversion to another dosing regimen (conversion to tacrolimus, prograf, etc.)
Time frame: 6 months
Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180
Due to a small number of events, median time to \<event\> was not reached.
Time frame: 6 months
Time to "Event" for the Composite Endpoint as Well as All Individual Components of That Endpoint "Treatment Failure" Including Clinical Rejections
Due to a small number of events, median time to \<event\> was not reached.
Time frame: 6 months
Renal Function as Measured by Serum Creatinine
Time frame: 6 months
Renal Function as Measured by Glomerular Filtration Rate (GFR)
The Glomerular Filtration Rate (GFR) was calculated using the following formulas: * Cockcroft-Gault formula: calculation using the participant's age, gender, weight, and serum creatinine levels. * MDRD formula: calculation using the participant's age, gender, serum creatinine, urea nitrogen, and albumin levels.
Time frame: 6 months
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