title: One-Year Multicenter Double-Blind Randomized Clinical Trial on the Efficacy and Safety of Generic Cyclosporine (Iminoral) in De Novo Kidney Transplant Recipients.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Nephrology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Seyyed Mohammad Reza
authors.initials: SM
authors.lastname: Khatami
authors.forename: Shahram
authors.initials: S
authors.lastname: Taheri
authors.forename: Jalal
authors.initials: J
authors.lastname: Azmandian
authors.forename: Mohammad Mahdi
authors.initials: MM
authors.lastname: Sagheb
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Nazemian
authors.forename: Effat
authors.initials: E
authors.lastname: Razeghi
authors.forename: Sharzad
authors.initials: S
authors.lastname: Shahidi
authors.forename: Farzaneh
authors.initials: F
authors.lastname: Sadri
authors.forename: Ahmad Reza
authors.initials: AR
authors.lastname: Shamshiri
authors.forename: Mohammad
authors.initials: M
authors.lastname: Sayyah
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D065095:Calcineurin Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D016568:Drugs, Generic / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006084:Graft Rejection / Q000175:diagnosis / Q000276:immunology / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007492:Iran; D016030:Kidney Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D065095:Calcineurin Inhibitors; D016568:Drugs, Generic; C523752:Iminoral; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid