Everolimus (certican) 12-month safety and efficacy versus mycophenolate mofetil in de Novo renal transplant recipients

Transplantation

Volumn 78, Issue 10, 2004, Pages 1532-1540

  Vítko, Štefan ^a   Margreiter, Raimund ^b   Weimar, Willem ^c   Dantal, Jacques ^d   Viljoen, Hendrik G ^e   Li, Yulan ^f   Jappe, Annette ^f   Cretin, Nathalie ^f  

^a INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE   (Czech Republic)

^b UNIVERSITY HOSPITAL INNSBRUCK   (Austria)

^c ERASMUS MEDICAL CENTER   (Netherlands)

^d HÔTEL DIEU   (France)

^e Garden City Clinic   (South Africa)

^f NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Cytomegalovirus; Everolimus; Kidney transplant; Mycophenolate mofetil; Rejection

Indexed keywords

ACICLOVIR; ANTILIPEMIC AGENT; ATORVASTATIN; CORTICOSTEROID; COTRIMOXAZOLE; CYCLOSPORIN A; EVEROLIMUS; FLUINDOSTATIN; GANCICLOVIR; HYPERIMMUNE GLOBULIN; LYMPHOCYTE ANTIBODY; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PRAVASTATIN; PREDNISONE; THYMOCYTE ANTIBODY;

ACUTE GRAFT REJECTION; ADULT; AGED; ANEMIA; ARTICLE; CANDIDIASIS; CHRONIC GRAFT REJECTION; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DIABETES MELLITUS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; HYPERTENSION; HYPERTRIGLYCERIDEMIA; INCIDENCE; KIDNEY GRAFT; LEUKOPENIA; LIVING DONOR; LYMPHOCELE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PNEUMOCYSTOSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; THROMBOCYTOPENIA;

ADOLESCENT; ADULT; AGED; BIOPSY; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; METHYLPREDNISOLONE; MIDDLE AGED; MYCOPHENOLIC ACID; SAFETY; SIROLIMUS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 9244246780     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.TP.0000141094.34903.54     Document Type: Article

References (30)

1. Kovarik JM, Kahan BD, Kaplan B, et al. Longitudinal assessment of everolimus in de novo renal transplant recipients over the first post-transplant year: pharmacokinetics, exposure-response relationships, and influence on cyclosporine. Clin Pharmacol Ther 2001; 69: 48.
2. Kirchner GI, Winkler M, Mueller L, et al. Pharmacokinetics of SDZ RAD and cyclosporin including their metabolites in seven kidney graft patients after the first dose of SDZ RAD. Br J Clin Pharmacol 2000; 50: 449.
3. Schuler W, Sedrani R, Cottens S, et al. SDZ RAD, a new rapamycin derivative. Pharmacologic properties in vitro and in vivo. Transplantation 1997; 64: 36.
4. Hausen B, Gummert J, Berry GJ, et al. Prevention of acute allograft rejection in nonhuman primate lung transplant recipients: induction with chimeric anti-interleukin-2 receptor monoclonal antibody improves the tolerability and potentiates the immunosuppressive activity of a regimen using low doses of both microemulsion cyclosporine and 40-O-(2-hydroxyethyl)- rapamycin. Transplantation 2000; 69: 488.
5. Hausen B, Boeke K, Berry GJ, et al. Suppression of acute rejection in allogenic rat lung transplantation: a study of the efficacy and pharmacokinetics of rapamycin derivative (SDZ RAD) used alone and in combination with a microemulsion formulation of cyclosporine. J Heart Lung Transplant 1999; 18: 150.
6. Schuurman HJ, Cotten S, Fuchs S, et al. SDZ RAD, a new rapamycin derivative: synergism with cyclosporine. Transplantation 1997; 64: 32.
7. Serkova N, Hausen B, Berry GJ, et al. Tissue distribution and clinical monitoring of the novel macrolide immunosuppressant SDZ-RAD and its metabolites in monkey lung transplant recipients: interaction with cyclosporine. J Pharmacol Exp Ther 2000; 294: 323.
8. Hausen B, Boeke K, Berry GJ, et al. Coadministration of Neoral and the novel rapamycin analog, SDZ RAD, to rat lung allograft recipients: potentiation of immunosuppressive efficacy and improvement of tolerability of staggered simultaneous treatment. Transplantation 1999; 67: 956.
9. Curtis J, Nashan B, Ponticelli C, et al. One year results of a multicenter, open-label trial on safety and efficacy of Certican™ (RAD) used in combination with Simulect®, corticosteroids, and full or reduced dose Neoral® in renal transplantation [abstract]. Am J Transplant 2001; 1(Suppl 1): 474.
10. Nashan B. The role of Certican™ (everolimus, RAD) in the many pathways of chronic rejection. Transplant Proc 2001; 33: 3210.
11. Mele TS, Halloran PF. The use of mycophenolate mofetil in transplant recipients. Immunopharmacology 2000; 47: 215.
12. Sollinger HW for the US Renal Transplant Mycophenolate Mofetil Study Group. Mycophenolate mofetil for the prevention of acute rejection in primary renal allograft recipients. Transplantation 1995; 60: 225.
13. The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection episodes in cadaveric renal transplantation. Transplantation 1996; 61: 1029.
14. Banff schema for grading liver allograft rejection: an international consensus document. Hepatology 1997; 25: 658.
15. Meier-Kriesche H-U, Ojo AO, Hanson JA, et al. Increased impact of acute rejection on chronic allograft failure in recent era. Transplantation 2000; 70: 1098.
16. Humar A, Kerr S, Gillingham KJ, et al. Features of acute rejection that increase risk for chronic rejection. Transplantation 1999; 68: 1200.
17. Tejani A, Sullivan EK. The impact of acute rejection on chronic rejection: a report of the North American Pediatric Renal Transplant Cooperative Study. Pediatr Transplant 2000; 4: 107.
18. Reference deleted.
19. Hausen B, Ikonen T, Briffa N, et al. Combined immunosuppression with cyclosporine (neural) an SDZ RAD in non-human primate lung transplantation: systematic pharmacokinetic-based trials to improve efficacy and tolerability. Transplantation 2000; 69: 76.
20. Cole OJ, Shehata M, Rigg KM. Effect of SDZ RAD on transplant arteriosclerosis in the rat aortic model. Transplant Proc 1998; 30: 2200.
21. Schuurman H-J, Pally C, Weckbecker G, et al. SDZ RAD inhibits cold ischemia-induced vascular remodeling. Transplant Proc 1999; 31: 1024.
22. Kaplan B, Tedesco-Silva H, Mendez R, et al. North/South American, double-blind, parallel group study of the safety and efficacy of Certican (RAD) versus mycophenolate mofetil (MMF) in combination with Neoral® and corticosteroids- 12-month analysis [abstract] Am J Transplant 2001; 1(Suppl 1): 475.
23. Kovarik JM, Rordorf C, McMahon L, et al. Exposure-response relationships for everolimus in de novo renal transplantation: toward defininga therapeutic range. Am J Transplant 2001; 1(Suppl 1): 474.
24. Soderberg-Nauclér S, Emery VC. Viral infections and their impact on chronic renal allograft dysfunction. Transplantation 2001; 71: SS24.
25. Tedesco H, Ambühl P, Lorber M, et al. Improved renal functioning following cyclosporine dose reduction in maintenance renal transplant recipients taking everolimus (Certican™). Presented at the American Transplant Congress; April 2002; Washington, DC.
26. Andoh TF, Lindsley J, Franceschini N, et al. Synergistic effects of cyclosporine and rapamycin in a chronic nephrotoxicity model. Transplantation 1996; 62: 311.
27. Morales JM, Andres A, Rengel M, et al. Influence of cyclosporin, tacrolimus and rapamycin on renal function and arterial hypertension after renal transplantation. Nephrol Dial Transplant 2001; 16(Suppl 1): 121.
28. Johnson RW, Kreis H, Oberbauer R, et al. Sirolimus allows early cyclosporine withdrawal in renal transplantation resulting in improved renal function and lower blood pressure. Transplantation 2001; 72: 777.
29. Ponticelli C, and the RAD B156 Study Group. Certican (everolimus, RAD) with reduced dose Neoral results in a significantly higher GFR in de novo renal transplant recipients over the first 12 months compared to Certican-full dose-Neoral as assessed by iohexol clearance. Presented at: New and Emerging Immunosuppressive Agents, Insights Into Mechanisms of Action and Clinical Trials, 2001: A Transplant Odyssey; August 20-23, 2001; Istanbul, Turkey.
30. Curtis J, Nashan B, Kovarik JM, et al. Everolimus (RAD) pharmacokinetics are unaltered with full dose versus reduced dose cyclosporine [abstract]. Am J Transplant 2001; 1(Suppl 1): 299.