One-Year Multicenter Double-Blind Randomized Clinical Trial on the Efficacy and Safety of Generic Cyclosporine (Iminoral) in De Novo Kidney Transplant Recipients.

OBJECTIVES: Iminoral is the generic microemulsion of cyclosporine. We performed a randomized double-blind multicenter trial to evaluate its efficacy and safety compared with the innovator medication Neoral for preventing acute rejection episodes in adult patients during the first year after renal transplant. MATERIALS AND METHODS: We used 221 de novo renal transplant recipients from 6 transplant centers in Iran enrolled between April 2008, and January 2010. They were randomized to receive either Iminoral or Neoral as the calcineurin inhibitor component of the immunosuppressive regimen in addition to mycophenolate mofetil and oral corticosteroids. They were followed-up for 1 year. The primary endpoint was the rate of acute allograft rejection. Secondary endpoints consisted of 1-year graft survival rates, daily dosages of cyclosporine, trough and C2 cyclosporine blood level, serum creatinine levels, patient death rates, discontinuing the study drug, tolerability, and adverse events. RESULTS: The risk of acute rejection episode during the first month after transplant was 9% for Iminoral and 10% for Neoral; these declined to 4% and 2% during next 11 months. One-year graft survival rate was 0.86 for both groups. Renal function stabilized during the first month. Declination of the creatinine levels was similar between the 2 groups and reached a stable value of 114.9 µmol/L five months after the transplant. The frequency of clinical complications was similar between the groups. CONCLUSIONS: Iminoral is safe and effective when used in de novo kidney transplant patients as an immunosuppressive medication.

Access recirculation in jugular venous catheter in regular and reversed lines.

INTRODUCTION: The aim of this study was to determine access recirculation in functioning catheters in the regular and reversed positions. MATERIALS AND METHODS: Access recirculation was measured in 2 sequential hemodialysis sessions in patients with functioning internal jugular catheters inserted not earlier than 2 weeks before the study. The arterial and venous lines were in their regular position during the first session and they were reversed during the second measurement. Changes in access recirculation were assessed. Also, type of the catheter and number of catheter insertions were evaluated in relation to access recirculation. RESULTS: Twenty-five of the patients had a permanent catheter and 5 had a temporary catheter. During the first session, the mean of access recirculation was 6.9 +/- 6.7% in the patients with a permanent catheter and 7.8 +/- 8.4% in those with a temporary catheter (P = .45). The mean access recirculation was 7.1 +/- 6.9% (range, 0 to 20%) in the 30 patients on hemodialysis with the arterial and venous lines in their regular positions. When the lines were reversed, access recirculation increased significantly (P = .01) to a mean of 20.5 +/- 20.5% (range, 2.3% to 75%). There was no significant correlation between the type of catheter or the number of catheter insertions and access recirculation. CONCLUSIONS: After reversing the arterial and venous lines, access recirculation in both temporary and permanent functioning catheters may increase; therefore, dialysis adequacy might be impaired by reversed lines. Replacing malfunctioning catheters with new ones seems to be better than reversing the lines.