Two prospective, randomized studies evaluated everolimus 1.5 vs. 3 mg/day with steroids and lowexposure cyclosporine (CsA) (C 2 monitoring) in de novo renal transplant patients. Everolimus dosing was adjusted to maintain a minimum trough level of 3 ng/mL. Study 1 (A2306; n = = 237) had no induction therapy; in Study 2 (A2307; n = = 256) basiliximab was administered (Days 0 and 4). The primary endpoint was renal function at 6 months. CsA C 2 target levels, initially 1200 ng/mL in Study 1 and 600 ng/mL in Study 2, were tapered over time post-transplant. Median creatinine levels in Study 1 were 133 and 132 lmol/L at 6 months in the 1.5 and 3 mg/day groups, respectively, and 130 lmol/L in both groups in Study 2. Biopsyproven acute rejection (BPAR) occurred in 25.0% and 15.2% of patients in the 1.5 and 3 mg/day groups in Study 1, and 13.7% and 15.1% in Study 2. Incidence of BPAR was significantly higher in patients with an everolimus trough < < 3 ng/mL. There were no significant between-group differences in the composite endpoint of BPAR, graft loss or death, nor any significant between-group differences in adverse events in either study. Concentration-controlled everolimus with lowexposure CsA provided effective protection against rejection with good renal function.

Sirolimus has antineoplastic effects and may reduce skin cancer rates in kidney transplant patients. This prospective, multicenter, randomized, open-label, controlled trial randomized 86 kidney transplant recipients (≥1 year posttransplant) with history of nonmelanoma skin cancer (NMSC) to continue calcineurin inhibitor (CNI) or convert to sirolimus. Patients were stratified by number of NMSC lesions (0-5, 6-20) in previous year. Primary end point was number of biopsy-confirmed new NMSC lesions per patient-year. Yearly NMSC rate was significantly lower with sirolimus (1.31 vs. 2.48 lesions/patient-year; p = 0.022). Squamous cell carcinoma occurred at a lower rate in the sirolimus versus CNI group (p = 0.038); basal cell carcinoma rate was similar in both. A lower proportion of patients receiving sirolimus developed new or recurrent NMSC (56.4% vs. 80.9%; p = 0.015) or new squamous cell carcinoma (41.0% vs. 70.2%; p = 0.006). No sirolimus patients and one CNI continuation patient experienced acute rejection. Incidence of treatment-emergent adverse events was similar between groups; however, discontinuation rates related to adverse events were significantly higher with sirolimus (46.2% vs. 0%; p < 0.001). In kidney transplant recipients with history of NMSC, conversion from CNI to sirolimus reduced rates of NMSC, without increasing acute rejection risk.

The only significant adverse effect of obesity on renal transplant outcomes was an increase in wound complications, which were generally of minor consequence. Provided that adequate care is taken to avoid transplanting patients with significant cardiovascular disease, obese recipients can achieve excellent long-term patient and graft survivals that are on par with their nonobese counterparts. Denying patients access to renal transplantation on the basis of obesity per se does not appear to be justified.

An endoAVF can be reliably created using a radiofrequency magnetic catheter-based system, without open surgery and with minimal complications. The endoAVF can be successfully used for hemodialysis and demonstrated high 12-month cumulative patencies. It may be a viable alternative option for achieving AVFs for hemodialysis patients in need of vascular access.

♦ Objective The aim of this study was to prospectively evaluate the risk factors for decline of residual renal function (RRF) in an incident peritoneal dialysis (PD) population. ♦ Design Prospective observational study of an incident PD cohort at a single center. ♦ Setting Tertiary-care institutional dialysis center. ♦ Participants The study included 146 consecutive patients commencing PD at the Princess Alexandra Hospital between 1 August 1995 and 1 July 2001 (mean age 54.8 ± 1.4 years, 42% male, 34% diabetic). Patients with failed renal transplants ( n = 26) were excluded. ♦ Main Measurements Timed urine collections ( n = 642) were performed initially and at 6-month intervals thereafter to measure RRF. The development of anuria was also prospectively recorded. ♦ Results The mean (±SD) follow-up period was 20.5 ± 14.8 months. The median slope of RRF decline was –0.05 mL/minute/month/1.73 m2. Using binary logistic regression, it was shown that the 50% of patients with more rapid RRF loss (< –0.05 mL/min/month/1.73 m2) were more likely to have had a higher initial RRF at commencement of PD [adjusted odds ratio (AOR) 1.83, 95% confidence interval (CI) 1.39 – 2.40] and a higher baseline dialysate/plasma creatinine ratio at 4 hours (D/P creat; AOR 44.6, 95% CI 1.05 – 1900). On multivariate Cox proportional hazards model analysis, time from commencement of PD to development of anuria was independently predicted by baseline RRF [adjusted hazard ratio (HR) 0.81, 95% CI 0.60 – 0.81], D/P creat (HR 2.87, 95% CI 2.06 – 82.3), body surface area (HR 6.23, 95% CI 1.53 – 25.5), dietary protein intake (HR 2.87, 95% CI 1.06 – 7.78), and diabetes mellitus (HR 1.65, 95% CI 1.00 – 2.72). Decline of RRF was independent of age, gender, dialysis modality, urgency of initiation of dialysis, smoking, vascular disease, blood pressure, medications (including angiotensin-converting enzyme inhibitors), duration of follow-up, and peritonitis rate. ♦ Conclusions The results of this study suggest that high baseline RRF and high D/P creat ratio are risk factors for rapid loss of RRF. Moreover, a shorter time to the onset of anuria is independently predicted by low baseline RRF, increased body surface area, high dietary protein intake, and diabetes mellitus. Such at-risk patients should be closely monitored for early signs of inadequate dialysis.

Metabolic syndrome occurs in 30.5% of stages 4 and 5 CKD patients and is associated with older age, peritoneal dialysis, ethnicity, increased oxidative stress, lower serum adiponectin concentrations and a significantly increased risk of future cardiovascular events. Intervention strategies targeting hypercholesterolaemia, hyperhomocysteinaemia, anaemia and disordered bone mineral metabolism may not be effective in ameliorating the heightened cardiovascular risk of CKD patients with MS.

The clinical usefulness of hemodialysis catheters is limited by increased infectious morbidity and mortality. Topical antiseptic agents, such as mupirocin, are effective at reducing this risk but have been reported to select for antibiotic-resistant strains. The aim of the present study was to determine the efficacy and the safety of exit-site application of a standardized antibacterial honey versus mupirocin in preventing catheter-associated infections. A randomized, controlled trial was performed comparing the effect of thrice-weekly exit-site application of Medihoney versus mupirocin on infection rates in patients who were receiving hemodialysis via tunneled, cuffed central venous catheters. A total of 101 patients were enrolled. The incidences of catheter-associated bacteremias in honey-treated (n ‫؍‬ 51) and mupirocin-treated (n ‫؍‬ 50) patients were comparable (0.97 versus 0.85 episodes per 1000 catheter-days, respectively; NS). On Cox proportional hazards model analysis, the use of honey was not significantly associated with bacteremia-free survival (unadjusted hazard ratio, 0.94; 95% confidence interval, 0.27 to 3.24; P ‫؍‬ 0.92). No exit-site infections occurred. During the study period, 2% of staphylococcal isolates within the hospital were mupirocin resistant. Thrice-weekly application of standardized antibacterial honey to hemodialysis catheter exit sites was safe, cheap, and effective and resulted in a comparable rate of catheter-associated infection to that obtained with mupirocin (although the study was not adequately powered to assess therapeutic equivalence). The effectiveness of honey against antibiotic-resistant microorganisms and its low likelihood of selecting for further resistant strains suggest that this agent may represent a satisfactory alternative means of chemoprophylaxis in patients with central venous catheters.

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