Tacrolimus once daily (ADVAGRAF) versus twice daily (PROGRAF) in de novo renal transplantation: A randomized phase III study

American Journal of Transplantation

Volumn 10, Issue 12, 2010, Pages 2632-2643

  Kramer B K ^a   Charpentier, B ^b   Backman L ^c   Silva Jr , H Tedesco ^d   Mondragon Ramirez, G ^e   Cassuto Viguier, E ^f   Mourad, G ^g   Sola, R ^h   Rigotti, P ⁱ   Mirete, J Ortuno ^j  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b BICÊTRE HOSPITAL   (France)

^c UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^d FEDERAL UNIVERSITY OF SÃO PAULO   (Brazil)

^e Instituto Mexicano de Transplantes   (Mexico)

^f Service de Nephrologie   (France)

^g LAPEYRONIE HOSPITAL   (France)

^h FUNDACIÓ PUIGVERT   (Spain)

ⁱ UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^j HOSPITAL RAMÓN Y CAJAL   (Spain)

more..

Author keywords

Biopsy proven acute rejection; immunosuppression; kidney transplantation; noninferiority study; prolonged release tacrolimus; tacrolimus

Indexed keywords

CREATININE; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISOLONE; TACROLIMUS;

ABDOMINAL PAIN; ADULT; ANEMIA; ARTHRALGIA; ARTICLE; BACTERIAL INFECTION; BLEEDING; CHRONIC PYELONEPHRITIS; CLINICAL TRIAL; COMPARATIVE STUDY; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; CYTOMEGALOVIRUS INFECTION; DIABETES MELLITUS; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG INDUCED CANCER; DRUG INDUCED HEADACHE; DRUG WITHDRAWAL; DYSMENORRHEA; EVENING DOSAGE; FEMALE; GASTROENTERITIS; GLOMERULUS FILTRATION RATE; GRAFT DYSFUNCTION; GRAFT RECIPIENT; GRAFT SURVIVAL; HEMATOMA; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; HYPERKALEMIA; HYPERTENSION; HYPOKALEMIA; INFECTION; INSOMNIA; INSULIN DEPENDENT DIABETES MELLITUS; KIDNEY BIOPSY; KIDNEY DISEASE; KIDNEY FUNCTION; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; KIDNEY TUBULE NECROSIS; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MORNING DOSAGE; MULTICENTER STUDY; NAUSEA; NEUROLOGIC DISEASE; NIGHT SWEAT; PATIENT COMPLIANCE; PERIPHERAL EDEMA; PHARYNGITIS; PHASE 3 CLINICAL TRIAL; POLYOMAVIRUS INFECTION; PRIORITY JOURNAL; SIDE EFFECT; TESTIS DISEASE; TINEA; TREMOR; URINARY TRACT INFECTION; VOMITING;

ADULT; AGED; DELAYED-ACTION PREPARATIONS; DRUG ADMINISTRATION SCHEDULE; FEMALE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; TACROLIMUS;

EID: 78649896434     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2010.03256.x     Document Type: Article

References (28)

1. Vasquez E, Tanzi, Benedetti E, Pollak R,. Medication noncompliance after kidney transplantation. Am J Health-Syst Pharm 2003; 60: 266-269.
2. Gaston R, Hudson S, Ward M, Jones P, Macon R,. Late renal allograft loss: Non-compliance masquerading as chronic rejection. Transplant Proc 1999; 31 (Suppl 4A): 21S-23S.
3. Matas A, Humar A, Gillingham K, et al,. Five preventable causes of kidney graft loss in the 1990s: A single-center analysis. Kidney Int 2002; 62: 704-714.
4. Weng FL, Israni AK, Joffe MM, et al,. Race and electronically measured adherence to immunosuppressive medications after deceased donor renal transplantation. J Am Soc Nephrol 2005; 16: 1839-1848.
5. Ichimaru N, Kakuta Y, Abe T, et al,. Treatment adherence in renal transplant recipients: A questionnaire survey on immunosuppressants. Transplant Proc 2008; 40: 1362-1365.
6. Chisholm M, Mulloy L, DiPiro J,. Comparing renal transplant patients' adherence to free cyclosporine and free tacrolimus immunosuppressant therapy. Clin Transplant 2005; 19: 77-82.
7. Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC,. Frequency and impact of non-adherence to immunosuppressants after renal transplantation: A systematic review. Transplantation 2004; 77: 769-789.
8. Takemoto SK, Pinsky BW, Schnitzler MA, et al,. A retrospective analysis of immunosuppression compliance, dose reduction and discontinuation in kidney transplant recipients. Am J Transplant 2007; 7: 2704-2711.
9. Cross SA, Perry CM,. Tacrolimus once-daily formulation: In the prophylaxis of transplant rejection in renal or liver allograft recipients. Drugs 2007; 67: 1931-1943.
10. Racusen LC, Solez K, Colvin RB, et al,. The Banff 97 working classification of renal allograft pathology. Kidney Int 1999; 55: 713-723.
11. Squifflet J, Backman L, Claesson K, et al,. Dose optimization of mycophenolate mofetil when administered with a low dose of tacrolimus in cadaveric renal transplant recipients. Transplantation 2001; 72: 63-69.
12. Rostaing L, Cantarovich D, Mourad G, et al,. Corticosteroid-free immunosuppression with tacrolimus, mycophenolate mofetil, and daclizumab induction in renal transplantation. Transplantation 2005; 79: 807-814.
13. Vanrenterghem Y, Van Hooff J, Squifflet J, et al,. Minimization of immunosuppressive therapy after renal transplantation: Results of a randomized controlled trial. Am J Transplant 2005; 5: 87-95.
14. Vitko S, Wlodarczyk Z, Kyllonen L, et al,. Tacrolimus combined with two different dosages of sirolimus in kidney transplantation: Results of a multicenter study. Am J Transplant 2006; 6: 531-538.
15. Â) in de novo kidney transplant recipients in a phase III multicentre study [abstract 527]. Transplantation 2008; 86: 184-185.
16. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D,; for the Modification of Diet in Renal Disease Study Group. A more accurate method to estimate glomerular filtration rate for serum creatinine: A new prediction equation. Ann Intern Med 1999; 130: 461-470.
17. Quiroga I, McShane P, Koo D, et al,. Major effects of delayed graft function and cold ischaemia time on renal allograft survival. Nephrol Dial Transplant 2006; 21: 1689-1696.
18. Scott LJ, McKeage K, Keam SJ, Plosker GL,. Tacrolimus: A further update of its use in the management of organ transplantation. Drugs 2003; 63: 1247-1297.
19. Van Hooff JP, Alloway R, Trunečka P,. Four-year experience with tacrolimus once-daily prolonged release (TAC QD) in kidney, liver and heart recipients [abstract 463]. Am J Transplant 2009; 9 (Suppl 2): 325.
20. Silva Jr HT, Yang HC, Abouljoud M, et al,. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients [published erratum appears in Am J Transplant 2007; 7: 1682]. Am J Transplant 2007; 7: 595-608.
21. Â (cyclosporine)/MMF in de novo kidney transplant recipients: 2 year results [abstract 144]. Am J Transplant 2007; 7 (Suppl 2): 183.
22. Van Hooff JP, Alloway R, Trunečka P, Squifflet J-P,. Three-year experience with tacrolimus once-daily prolonged release in kidney, liver and heart recipients. Transplantation 2008; 86 (Suppl 2S): 185-186.
23. Alloway R, Steinberg S, Khalil K, et al,. Two years postconversion from a Prograf-based regimen to a once-daily tacrolimus extended-release formulation in stable kidney transplant recipients. Transplantation 2007; 83: 1648-1651. (Pubitemid 46987920)
24. Muñoz P, Fogeda M, Bouza E, Verde E, Palomo J, Bañares R,; BKV Study Group. Prevalence of BK virus replication among recipients of solid organ transplants. Clin Infect Dis 2005; 41: 1720-1725.
25. Wlodarczyk Z, Squifflet J-P, Ostrowski M, et al,. Pharmacokinetics for once- versus twice-daily tacrolimus formulations in de novo kidney transplantation: A randomized, open-label trial. Am J Transplant 2009; 9: 2505-2513.
26. Squifflet J-P, Backman L, Claesson K, et al,. Dose optimization of mycophenolate mofetil when administered with a low dose of tacrolimus in cadaveric renal transplant recipients. Transplantation 2001; 72: 63-69.
27. Poggio E, Wang X, Weinstein D, et al,. Assessing glomerular filtarion rate by estimation equations in kidney transplant recipients. Am J Transplant 2006; 6: 100-108.
28. Banas B, Krämer B, Charpentier B, et al,.; for the Tacrolimus Prolonged Release Renal Study Group. Tacrolimus once-daily prolonged release versus tacrolimus twice daily in combination with MMF and steroids-a phase III multicentre renal study [abstract 1628]. Transplantation 2008; 86: 184-185.