Premium
Renal function with cyclosporine C 2 monitoring, enteric‐coated mycophenolate sodium and basiliximab: a 12‐month randomized trial in renal transplant recipients
Author(s) -
Cibrik Diane,
MeierKriesche HerwigUlf,
Bresnahan Barbara,
Wu You Min,
Klintmalm Goran,
Kew Clifton E.,
Kuo Paul C,
Whelchel John,
Cohen David,
Baliga Prabakar,
Akalin Enver,
Benedetti Enrico,
Wright Francis,
Lieberman Bonnie,
Ulbricht Bettina,
Jensik Stephen
Publication year - 2007
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/j.1399-0012.2006.00622.x
Subject(s) - medicine , basiliximab , renal function , creatinine , transplantation , gastroenterology , adverse effect , mycophenolic acid , urology , randomized controlled trial , area under the curve , kidney transplantation , surgery
Background: Cyclosporine exposure, as estimated by the area under the curve (AUC), predicts outcomes in renal transplantation. Cyclosporine concentration at two h post‐dose (C 2 ) has been shown to be the most reliable, single‐point surrogate marker for AUC. The objective of this study was to measure renal function beyond month 2 post‐transplant using two different C 2 maintenance targets in combination with enteric‐coated mycophenolate sodium (EC‐MPS), corticosteroids, and basiliximab induction. Methods: In this open‐label, multicenter trial, renal transplant recipients entered one of two randomized groups at day 61 post‐transplant: group A (higher‐C 2 range) or group B (lower‐C 2 range). Results: Patients (164) were recruited, and 141 patients were entered the randomized groups (group A, n = 66; group B, n = 75). At 12 months, the mean calculated creatinine clearance was significantly greater in group B than in group A (79.2 vs. 71.0 mL/min, p < 0.05). Biopsy‐proven acute rejection occurred in 14.7% patients in group B and in 24.2% patients in group A (n.s.). During the 12‐month trial, 17.7% patients discontinued EC‐MPS because of adverse events. Group B (44.0%) had fewer serious adverse events when compared with group A (62.1%; p = 0.04). Overall patient and graft survival were 99.4% and 95.7% respectively. Among 99 high‐risk patients (i.e., African‐American race, previous transplant, PRA >35% or >4 HLA mismatches), mean creatinine clearance at 12 months was 65.6 mL/min and biopsy‐proven rejection occurred in 20.2% patients. Conclusions: Low cyclosporine C 2 levels are associated with improved renal function compared with higher C 2 levels when used in conjunction with EC‐MPS, steroids and basiliximab induction. EC‐MPS with low cyclosporine C 2 levels, corticosteroids and basiliximab provides excellent renal function with good efficacy even in high‐risk patients.