ABSTRACT. Uncertainty exists regarding the necessity of continuing triple therapy consisting of mycophenolate mofetil (MMF), cyclosporine (CsA), and prednisone (Pred) after kidney transplantation (RTx). At 6 mo after RTx, 212 patients were randomized to stop CsA (n = 63), stop Pred (n = 76), or continue triple drug therapy (n = 73). The MMF dose was 1000 mg twice daily, target CsA trough levels were 150 ng/ml, and Pred dose was 0.10 mg/kg per d. Follow-up was until 24 mo after RTx. Biopsy-proven acute rejection occurred in 14 (22%) of 63 patients after CsA withdrawal compared with 3 (4%) of 76 in the Pred withdrawal group (P = 0.001) and 1 (1.4%) of 73 in the control group (P = 0.0001). Biopsy-proven chronic rejection was present in one patient in the control group, in nine patients after CsA withdrawal (P = 0.006 versus control group); and in four patients after discontinuation of Pred (NS). Graft loss occurred in two versus one patient after CsA or Pred withdrawal, respectively, and in two patients in the control group (NS). Patients who successfully withdrew CsA had a significantly lower serum creatinine during follow-up. Pred withdrawal resulted in a reduction in mean arterial pressure, and the total cholesterol/HDL ratio increased. In conclusion, rapid CsA withdrawal at 6 mo after RTx results in a significantly increased incidence of biopsy-proven acute and chronic rejection. Pred withdrawal was safe and resulted in a reduction in mean arterial pressure. However, patient and graft survival and renal function 2 yr after RTx were not different among groups.
Patients returning to haemodialysis or peritoneal dialysis after a failed kidney transplantation sometimes have a renal allograft left in situ for some urine production. Low-dose immunosuppressive medication is often continued in such patients. To evaluate the morbidity and mortality between patients in time periods with (group A) or without (group B) low-dose maintenance immunosuppression, the present study was initiated. In a multi-centre cohort study we analysed data from patient files, which showed failure after at least 3 months graft function between 10 August 1972 and 4 April 1996, including 197 kidney transplantations. A total of 1.7 versus 0.51 infections per patient year was found in groups A and B, respectively (odds ratio [OR]: 3.4, 95% confidence interval [CI]: 2.5-4.5). There was an increased mortality in group A compared to group B (OR 3.4, 95% CI: 1.8-6.3), both from infectious disease (OR 2.8, 95% CI: 1.1-7.0), and cardiovascular disease (OR 4.9, 95% CI: 1.8-13.5). Continuation of immunosuppressive medication did not lead to fewer rejections (defined as a painful, tender graft and/or haematuria and/or low-grade non-infectious fever). Transplantectomy-related morbidity and mortality were acceptable. The increase in morbidity and mortality associated with low-dose maintenance immunosuppression argues in favour of stopping these medicaments when failed renal allograft patients return to dialysis.
Aims To evaluate the effect of corticosteroids on tacrolimus pharmacokinetics. Methods In a randomized trial, kidney transplant recipients were treated with tacrolimus and mycophenolate mofetil with either daclizumab ( n = 31) or 3 months of prednisone ( n = 34). Tacrolimus dose-adjusted predose concentrations ( C 0 ) at month 1-6 were compared between both groups and within the corticosteroid group before and after prednisone withdrawal. Results At month 1 the tacrolimus dose-adjusted C 0 in the corticosteroid group was 83 ± 8 vs 119 ± 17 ng ml -1 mg -1 kg -1 in the daclizumab group. The tacrolimus doseadjusted C 0 within the corticosteroid group at month 1 and 2 was 42% and 29% lower compared with month 4 ( P < 0.001). Conclusions A higher tacrolimus dose is required to reach target concentrations when used in combination with corticosteroids.
Early home-based group education supports informed decision-making regarding primary RRT for ESRD patients and their social networks and may remove barriers to pre-emptive transplantation.
SummaryKnowledge is a prerequisite for promoting well-informed decision-making. Nevertheless, there is no validated and standardized test to assess the level of knowledge among renal patients regarding kidney disease and all treatment options. Therefore, the objective of this study was to investigate the psychometric properties of such a questionnaire for use in research and practice. A 30-item list was validated in four groups: (1) 187 patients on dialysis, (2) 82 patients who were undergoing living donor kidney transplantation the following day, (3) the general population of Dutch residents (n = 515) and (4) North American residents (n = 550). The psychometric properties of the questionnaire were examined using multidimensional item response theory (MIRT). Norm references were also calculated. Five items were found to distort ability estimates (Differential item functioning; DIF). MIRT analyses were subsequently carried out for the remaining 25 items. Almost all items showed good discrimination and difficulty parameters based on the fitted model. Two stable dimensions with 21 items were retrieved for which norm references for the Dutch and North American, dialysis and transplantation groups were calculated. This study resulted in a thorough questionnaire, the Rotterdam renal replacement knowledge-test, which enables reliable testing of patient's knowledge on kidney disease and treatment options in clinic and research.
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