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



Reza Khatami SM1 ; Taheri S2 ; Azmandian J3 ; Sagheb MM4 ; Nazemian F5 ; Razeghi E6 ; Shahidi S2 ; Sadri F1 ; Shamshiri AR7 ; Sayyah M8
Authors
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Authors Affiliations
  1. 1. The Nephrology Research Center, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. The Kidney Transplant Center of Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran
  3. 3. The Kidney Transplant Center of Afzali-pour Hospital, Kerman University of Medical Sciences, Kerman, Iran
  4. 4. The Kidney Transplant Center of Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
  5. 5. The Kidney Transplant Center of Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
  6. 6. The Kidney Transplant Center of Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran
  7. 7. The Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  8. 8. The Department of Physiology and Pharmacology, Pasteur Institute of Iran, Tehran, Iran

Source: Experimental and Clinical Transplantation Published:2015


Abstract

Objectives: Iminoral is the generic microemulsion of cyclosporine. We performed a randomized doubleblind 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. © Baskent University 2015 Printed in Turkey. All Rights Reserved.