Pharmacokinetics of sotrastaurin combined with tacrolimus or mycophenolic acid in de novo kidney transplant recipients

Transplantation

Volumn 91, Issue 3, 2011, Pages 317-322

  Kovarik, John M ^a   Steiger, Jürg U ^b   Grinyo, Josep M ^c   Rostaing, Lionel ^d   Arns, Wolfgang ^e   Dantal, Jacques ^f   Proot, Pieter ^a   Budde, Klemens ^g  

^a NOVARTIS PHARMA AG   (Switzerland)

^b UNIVERSITY HOSPITAL BASEL   (Switzerland)

^c HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^d CHU RANGUEIL   (France)

^e UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^f HÔTEL DIEU   (France)

^g CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

Pharmacokinetics; Protein kinase C; Sotrastaurin; Tacrolimus

Indexed keywords

BASILIXIMAB; CORTICOSTEROID; MYCOPHENOLIC ACID; SOTRASTAURIN; TACROLIMUS;

ACUTE GRAFT REJECTION; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CREATININE CLEARANCE; DRUG EFFICACY; DRUG METABOLISM; DRUG POTENTIATION; FEMALE; GRAFT RECIPIENT; HUMAN; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADOLESCENT; ADULT; AGED; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; ENZYME INHIBITORS; FEMALE; FOLLOW-UP STUDIES; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; PROSPECTIVE STUDIES; PYRROLES; QUINAZOLINES; TACROLIMUS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 79951513667     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0b013e318203860d     Document Type: Article

References (10)

1. Evenou JP, Wagner J, Zenke G, et al. The potent protein kinase C-selective inhibitor AEB071 (sotrastaurin) represents a new class of immunosuppressive agents affecting early T-cell activity. J Pharmacol Experiment Ther 2009; 330: 792.
2. Bruns C, Pally C, Beerli C, et al. AEB071, a novel oral inhibitor of early T-cell activation, prolongs rat cardiac allograft survival when used alone and in combination with cyclosporine, everolimus, or FTY720 [abstract]. Transplantation 2006; 82(suppl 3): 316.
3. Skvara H, Dawid M, Kleyn CE, et al. Potential therapeutic option for psoriasis with AEB071, a novel protein kinase C inhibitor. J Clin Invest 2008; 118: 3151.
4. Budde K, Sommerer C, Becker T, et al. Sotrastaurin, a novel small molecule inhibiting protein kinase C: First clinical results in renal-transplant recipients. Am J Transplant 2010; 10: 571.
5. Kovarik JM, Stitah S, Slade A, et al. Sotrastaurin and tacrolimus coad-ministration: Effects on pharmacokinetics and biomarker responses. J Clin Pharmacol 2010; 50: 1260.
6. Kuypers DRJ, Claes K, Evenepoel P, et al. Time-related clinical determinants of long-term tacrolimus pharmacokinetics in combination with mycophenolic acid and corticosteroids: Aprospective studyinone hundred de novo renal transplant recipients. Clin Pharmacokinet 2004; 43: 741.
7. Ihara H, Shinkuma D, Ichikawa Y, et al. Intra- and interindividual variation in the pharmacokinetics of tacrolimus (FK506) in kidney transplant recipients-Importance of trough level as a practical indicator. Int J Urol 1995; 2: 151.
8. Kovarik JM, Kaplan B, Tedesco Silva H, et al. Pharmacokinetics of an everolimus-cyclosporine immunosuppressive regimen over the first 6 months after kidney transplantation. Am J Transplant 2003; 3: 606.
9. Kahan BD, Napoli KL, Kelly PA, et al. Therapeutic drug monitoring of sirolimus: Correlations with efficacy and toxicity.Clin Transplant2000; 14: 97.
10. Kovarik JM, Stitah S, Slade A, et al. Sotrastaurin and cyclosporine drug interaction study in healthy subjects. Biopharm Drug Dispos 2010; 31: 331.