title: Clinical outcomes of renal transplantation using liquid chromatographic monitoring of tacrolimus.
abstract: It is suggested that specific methods of Tacrolimus monitoring rather than immunoassays which over-estimate Tacrolimus levels, should be used in transplant recipients. There is limited data, however, comparing clinical outcomes of renal transplantation using each of these techniques. In this study, 40 renal transplant recipients with Tacrolimus monitoring by Microparticle Enzyme Immunoassay (MEIA; target trough level 10-15 ng/ml) were compared with 40 patients monitored by High Performance Liquid Chromatography with Tandem Mass Spectrometry (HPLC-MS; target trough level 8-13 ng/ml). All received anti CD25 antibody induction and Mycophenolate Mofetil in a steroid sparing protocol. No demographic differences were seen between MEIA and HPLC-MS groups. All patients were followed for 6 months. Patient survival was 100% in both groups; graft survival was 100% in the MEIA group and 97.5% in the HPLC-MS group. The groups did not differ in the number of dose changes required in the first 6 months or in the number of patients displaying Tacrolimus levels within target range at three and six months. Delayed graft function occurred in 14 patients in the MEIA group and 12 patients in the HPLC-MS group (P = NS). Biopsy-proven acute rejection occurred in 4 patients in the MEIA group and 1 patient in the HPLC-MS group (P = 0.17). Biopsy proven acute Tacrolimus nephrotoxicity occurred in 6 patients in the MEIA group, and 7 in the HPLC-MS group (P = NS). No difference was seen in serum creatinine or estimated creatinine clearance at 3 or 6 months. No difference between groups was seen in systolic or diastolic blood pressure, or total cholesterol at 3 or 6 months. 2 patients in the MEIA group developed CMV disease and 1 developed posttransplantation diabetes mellitus. CMV and posttransplantation diabetes were not seen in the HPLC-MS group. 2 patients in each group developed reversible tremor. This study suggests that renal transplantation with HPLC-MS monitoring of Tacrolimus is safe and effective.
authors.affiliation: Renal and Transplant Units, St. Mary's Hospital, Paddington, London W2 1NY, United Kingdom. richardborrows@doctors.org.uk
authors.forename: Richard
authors.initials: R
authors.lastname: Borrows
authors.forename: Gary
authors.initials: G
authors.lastname: Chusney
authors.forename: Marina
authors.initials: M
authors.lastname: Loucaidou
authors.forename: Anthony
authors.initials: A
authors.lastname: James
authors.forename: Jose
authors.initials: J
authors.lastname: Stichbury
authors.forename: Jen
authors.initials: J
authors.lastname: Van Tromp
authors.forename: Tom
authors.initials: T
authors.lastname: Cairns
authors.forename: Megan
authors.initials: M
authors.lastname: Griffith
authors.forename: Nadey
authors.initials: N
authors.lastname: Hakim
authors.forename: Adam
authors.initials: A
authors.lastname: McLean
authors.forename: Andrew
authors.initials: A
authors.lastname: Palmer
authors.forename: Vassilios
authors.initials: V
authors.lastname: Papalois
authors.forename: David
authors.initials: D
authors.lastname: Taube
mesh_terms: D000328:Adult; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D016030:Kidney Transplantation; D008297:Male; D013058:Mass Spectrometry / Q000379:methods; D008875:Middle Aged; D015203:Reproducibility of Results; D016559:Tacrolimus / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus