Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation

Transplantation

Volumn 95, Issue 7, 2013, Pages 933-942

  Cibrik, Diane ^a   Silva Jr , Helio Tedesco ^b   Vathsala, Anantharaman ^c,j   Lackova, Eva ^d   Cornu Artis, Catherine ^e   Walker, Rowan G ^f,k   Wang, Zailong ^e   Zibari, Gazi B ^g   Shihab, Fuad ^h   Kim, Yu S ⁱ  

^a UNIVERSITY OF MICHIGAN   (United States)

^b HOSPITAL DO RIM E HIPERTENSÃO   (Brazil)

^c NATIONAL UNIVERSITY HEALTH SYSTEM   (Singapore)

^d Fakultna nemocnica s poliklinikou FD Roosevelta Banska Bystrica   (Slovakia)

^e NOVARTIS PHARMA AG   (Switzerland)

^f ALFRED HOSPITAL   (Australia)

^g Louisiana State Health Sciences Center   (United States)

^h UNIVERSITY OF UTAH   (United States)

ⁱ Yonsei University College of Medicine   (South Korea)

^j SINGAPORE GENERAL HOSPITAL   (Singapore)

^k ROYAL MELBOURNE HOSPITAL   (Australia)

more..

Author keywords

Calcineurin inhibitor toxicity; Cyclosporine; Everolimus; Renal function; Renal transplantation

Indexed keywords

BASILIXIMAB; CORTICOSTEROID; CREATININE; CYCLOSPORIN A; EVEROLIMUS; MYCOPHENOLIC ACID;

ACNE; ADULT; ANEMIA; ARTICLE; BK VIRUS INFECTION; CLINICAL PROTOCOL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CYTOMEGALOVIRUS INFECTION; DIABETES MELLITUS; DIARRHEA; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG RESPONSE; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; GLOMERULUS FILTRATION RATE; GRAFT REJECTION; HEALING; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; KIDNEY BIOPSY; KIDNEY TRANSPLANTATION; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MOUTH ULCER; NEOPLASM; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; TREATMENT FAILURE; URINARY TRACT INFECTION; WOUND;

ADRENAL CORTEX HORMONES; ADULT; CALCINEURIN; CYCLOSPORINE; DRUG MONITORING; DRUG THERAPY, COMBINATION; FEMALE; GLOMERULAR FILTRATION RATE; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KAPLAN-MEIER ESTIMATE; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; SIROLIMUS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84876290338     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0b013e3182848e03     Document Type: Article

References (21)

1. Halloran PF. Immunosuppressive drugs for kidney transplantation. N Engl J Med 2004; 351: 2715.
2. Jardine AG. Assessing the relative risk of cardiovascular disease among renal transplant patients receiving tacrolimus or cyclosporine. Transpl Int 2005; 18: 379.
3. Kramer BK, Zulke C, Kammerl MC, et al. Cardiovascular risk factors and estimated risk for CAD in a randomized trial comparing calcineurin inhibitors in renal transplantation. Am J Transplant 2003; 3: 982.
4. Meier-Kriesche HU, Schold JD, Srinivas TR, et al. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant 2004; 4: 378.
5. Chapman JR. Clinical renal transplantation: where are we now, what are our key challenges? Transplant Proc 2010; 42: S3.
6. Buchler M, Caillard S, Barbier S, et al. Sirolimus versus cyclosporine in kidney recipients receiving thymoglobulin, mycophenolate mofetil and a 6-month course of steroids. Am J Transplant 2007; 7: 2522.
7. Larson TS, Dean PG, Stegall MD, et al. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant 2006; 6: 514.
8. Budde K, Bosmans JL, Sennesael J, et al. Reduced-exposure cyclo-sporine is safe and efficacious in de novo renal transplant recipients treated with enteric-coated mycophenolic acid and basiliximab. Clin Nephrol 2007; 67: 164.
9. Tedesco-Silva H, Jr., Cibrik D, Johnston T, et al. Everolimus plus reduced-exposure CsA versus mycophenolic acid plus standardexposure CsA in renal-transplant recipients. Am J Transplant 2010; 10: 1401.
10. Budde K, Becker T, Arns W, et al. Everolimus-based, calcineurin- inhibitor-free regimen in recipients of de-novo kidney transplants: an open-label, randomised, controlled trial. Lancet 2011; 377: 837.
11. Tanaka T, Kyo M, Kokado Y, et al. Correlation between the Banff 97 classification of renal allograft biopsies and clinical outcome. Transpl Int 2004; 17: 59.
12. Vereerstraeten P, Abramowicz D, De PL, et al. Absence of deleterious effect on long-term kidney graft survival of rejection episodes with complete functional recovery. Transplantation 1997; 63: 1739.
13. Salvadori M, Rosati A, Bock A, et al. Estimated one-year glomerular filtration rate is the best predictor of long-term graft function following renal transplant. Transplantation 2006; 81: 202.
14. Helal I, Abderrahim E, Ben HF, et al. The first year renal function as a predictor of long-term graft survival after kidney transplantation. Transplant Proc 2009; 41: 648.
15. Resende L, Guerra J, Santana A, et al. First year renal function as a predictor of kidney allograft outcome. Transplant Proc 2009; 41: 846.
16. Meier-Kriesche HU, Baliga R, Kaplan B. Decreased renal function is a strong risk factor for cardiovascular death after renal transplantation. Transplantation 2003; 75: 1291.
17. Novartis Pharma AG. Data on file. 2009.
18. Racusen LC, Colvin RB, Solez K, et al. Antibody-mediated rejection criteriaVan addition to the Banff 97 classification of renal allograft rejection. Am J Transplant 2003; 3: 708.
19. Nankivell BJ, Gruenewald SM, Allen RD, et al. Predicting glome-rular filtration rate after kidney transplantation. Transplantation 1995; 59: 1683.
20. Levey AS, Bosch JP, Lewis JB, et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999; 130: 461.
21. Levey AS, Coresh J, Balk E, et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med 2003; 139: 137.