title: The role of the protocol biopsies in renal allograft recipients.
abstract: Subclinical rejection and long-term cyclosporine nephrotoxicity are well-known risk factors of chronic allograft nephropathy. In a prospective study 32 low-risk patients were randomized to either a reduced CsA dose (5 mg/kg/d) and daclizumab (group A, n = 16) for 7 months posttransplant with subsequent CsA tapering/withdrawal, or to a normal CsA dose (10 mg/kg/day) without daclizumab (group B, n = 16). Both groups received MMF and prednisone. Protocol biopsies were obtained at engraftment and 3 and 12 months after Tx. The number of rejection episodes was the primary endpoint. The secondary endpoints were: renal function, histological parameters related to CsA, and serum levels of TGF-beta and PDGF-BB. A low incidence of clinically suspected rejection episodes was observed (19% in group A and 12.4% in group B; P = NS). Although protocol biopsies showed 12 subclinical rejection episodes (six in group A, six in group B), serum creatinine levels were not different between the examined groups at 3 months. However, at 12 months, there was a statistically improved mean creatinine level in group A patients (1.2 mg/dL +/- 0.5 in group A vs 1.54 mg/dL in group B; P <.05). Chronic histopathologic changes were significant for biopsies at 3 and 12 months in both groups compared to the baseline findings for protocol biopsies (with no differences between groups, or between 3 and 12 months in both groups). Serum TGF-beta and PDGF-BB did not differ between the groups. Protocol biopsies may be useful to monitor safety and efficiency of new immunosuppressive protocols. Immunosuppressive regimens with low CsA doses followed by the drug's complete withdrawal seem to be efficient and safe in low-risk kidney allograft recipients.
authors.affiliation: Department of Transplantation Medicine and Nephrology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: T
authors.initials: T
authors.lastname: Baczkowska
authors.forename: A
authors.initials: A
authors.lastname: Perkowska-Francka
authors.forename: M
authors.initials: M
authors.lastname: Durlik
authors.forename: T
authors.initials: T
authors.lastname: Cieciura
authors.forename: E
authors.initials: E
authors.lastname: Nowacka-Cieciura
authors.forename: J
authors.initials: J
authors.lastname: Pazik
authors.forename: D
authors.initials: D
authors.lastname: Lewandowska
authors.forename: A
authors.initials: A
authors.lastname: Mroz
authors.forename: B
authors.initials: B
authors.lastname: Matlosz
authors.forename: A
authors.initials: A
authors.lastname: Chmura
authors.forename: Z
authors.initials: Z
authors.lastname: Galazka
authors.forename: M
authors.initials: M
authors.lastname: Lao
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001706:Biopsy / Q000379:methods*; D016572:Cyclosporine / Q000627:therapeutic use*; D000077561:Daclizumab; D004359:Drug Therapy, Combination; D006084:Graft Rejection / Q000276:immunology / Q000473:pathology*; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology / Q000473:pathology*; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011183:Postoperative Complications / Q000145:classification / Q000473:pathology; D014184:Transplantation, Homologous / Q000276:immunology / Q000473:pathology
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000077561:Daclizumab; D009173:Mycophenolic Acid