Renal function with cyclosporine C2 monitoring, enteric-coated mycophenolate sodium and basiliximab: a 12-month randomized trial in renal transplant recipients

:  Background:  Cyclosporine exposure, as estimated by the area under the curve (AUC), predicts outcomes in renal transplantation. Cyclosporine concentration at two h post‐dose (C2) has been shown to be the most reliable, single‐point surrogate marker for AUC. The objective of this study was to meas...

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Bibliographic Details
Published in:Clinical transplantation 2007-03, Vol.21 (2), p.192-201
Main Authors: Cibrik, Diane, Meier-Kriesche, Herwig-Ulf, 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
Format: Article
Language:English
Subjects:
Adult
Aged
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antibodies, Monoclonal - therapeutic use
Antiviral agents
Area Under Curve
Biological and medical sciences
C2 monitoring
Creatinine - blood
Cyclosporine - blood
cyclosporine microemulsion
enteric-coated mycophenolate sodium
Female
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Graft Rejection
high-risk recipient
Humans
Immunosuppressive Agents - therapeutic use
kidney transplant
Kidney Transplantation
Male
Medical sciences
Middle Aged
Monitoring, Physiologic
Mycophenolic Acid - analogs & derivatives
myfortic
Pharmacology. Drug treatments
Postoperative Period
Prognosis
Prospective Studies
Recombinant Fusion Proteins - therapeutic use
renal function
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Tablets, Enteric-Coated
Tissue, organ and graft immunology
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Summary::  Background:  Cyclosporine exposure, as estimated by the area under the curve (AUC), predicts outcomes in renal transplantation. Cyclosporine concentration at two h post‐dose (C2) 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 C2 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‐C2 range) or group B (lower‐C2 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 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 C2 levels are associated with improved renal function compared with higher C2 levels when used in conjunction with EC‐MPS, steroids and basiliximab induction. EC‐MPS with low cyclosporine C2 levels, corticosteroids and basiliximab provides excellent renal function with good efficacy even in high‐risk patients.
ISSN:0902-0063
1399-0012
DOI:10.1111/j.1399-0012.2006.00622.x