title: De novo use of a generic formulation of tacrolimus versus reference tacrolimus in kidney transplantation: evaluation of the clinical results, histology in protocol biopsies, and immunological monitoring.
abstract: The use of generic formulations of immunosuppressive drugs in renal transplantation has been and still is a controversial subject. The lack of clinical studies about safety and efficacy in transplant patients is one of the factors restricting the diffusion of generic drugs in the renal transplant field. Since March 2013, our transplant unit has incorporated generic tacrolimus (Adoport(®) ; Sandoz), replacing the one we were currently using (Prograf(®) ; Astellas). When carrying out our retrospective analysis comparing the two different formulations, we evaluated several clinical results: tacrolimus trough concentrations (C0) at 5-7 days; 1, 3, and 6 months post-transplantation; concentration/dose ratio at 6 months; acute rejection incidence; delayed graft function (DGF); renal function (as CKD-EPI); and proteinuria at 6 months in 120 patients (1:1 ratio of Prograf(®) versus Adoport(®) ), noticing no important differences. We also evaluated the results of protocol biopsies at 6 months in a subgroup of patients, thus verifying the safety and efficacy of this particular generic drug versus the reference product on a histological basis as well. No difference in the development of dnDSA (de novo donor-specific antibody) was found between the two groups.
authors.affiliation: Bellvitge University Hospital, Department of Nephrology, Renal Transplantation Unit carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Melilli
authors.affiliation: IDIBELL, Department of Experimental Nephrology, Carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Elena
authors.initials: E
authors.lastname: Crespo
authors.affiliation: Bellvitge University Hospital, Department of Nephrology, Renal Transplantation Unit carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Diego
authors.initials: D
authors.lastname: Sandoval
authors.affiliation: Bellvitge University Hospital, Department of Nephrology, Renal Transplantation Unit carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.|IDIBELL, Department of Experimental Nephrology, Carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Manonelles
authors.affiliation: Bellvitge University Hospital, Department of Nephrology, Renal Transplantation Unit carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Neus
authors.initials: N
authors.lastname: Sala
authors.affiliation: Department of Radiology, Bellvitge University Hospital, Carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Richard
authors.initials: R
authors.lastname: Mast
authors.affiliation: Department of Pharmacy, Bellvitge University Hospital, Carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Ariadna
authors.initials: A
authors.lastname: Padulles
authors.affiliation: Bellvitge University Hospital, Department of Nephrology, Renal Transplantation Unit carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Josep M
authors.initials: JM
authors.lastname: Grinyo
authors.affiliation: Bellvitge University Hospital, Department of Nephrology, Renal Transplantation Unit carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.|IDIBELL, Department of Experimental Nephrology, Carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Oriol
authors.initials: O
authors.lastname: Bestard
authors.affiliation: Bellvitge University Hospital, Department of Nephrology, Renal Transplantation Unit carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.|IDIBELL, Department of Experimental Nephrology, Carrer de la feixa llarga L'Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Josep Maria
authors.initials: JM
authors.lastname: Cruzado
mesh_terms: D000328:Adult; D000368:Aged; D000906:Antibodies / Q000737:chemistry; D001706:Biopsy; D015331:Cohort Studies; D051799:Delayed Graft Function; D004334:Drug Administration Schedule; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006084:Graft Rejection / Q000276:immunology; D006801:Humans; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007668:Kidney / Q000502:physiology; D016030:Kidney Transplantation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D015166:Monitoring, Immunologic; D061214:Patient Safety; D011507:Proteinuria / Q000150:complications; D012016:Reference Values; D012189:Retrospective Studies; D016559:Tacrolimus / Q000008:administration & dosage* / Q000627:therapeutic use; D013927:Thrombosis; D014019:Tissue Donors; D016896:Treatment Outcome
chemical_list: D000906:Antibodies; D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: donor-specific antibody; generic drugs; kidney transplantation; protocol biopsy; renal transplantation; tacrolimus; tacrolimus trough concentrations