Trial | NCT00656695  Report issue

Title

Comparisone of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation
The Comparison Between Clinical and Paraclinical Effect of Iminoral Vs Neoral in Prevention of Acute Rejection in the First Year Afer Transplantation in De Novo Renal Transplant Patients

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    208
Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more than 2500 new renal transplantation each year and because of this the government pay a huge amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an Iranian drug company introduced this drug in the name of Iminoral which has been approved by different authorities in Iran and abroad, (including the Ministry of Health in Iran and also European Directorate for the Quality of Medicines Certification Unit and FDA(Department of Health and Human Services,Center for Drug Evaluation and Research)). The investigators study is the first clinical trial to compare the effect of Iminoral versus Neoral in preventing acute rejection in renal transplantation and also to compare the side effects of these two drugs.
Study Started
Apr 30
2008
Primary Completion
Apr 30
2009
Study Completion
Oct 31
2009
Last Update
Jun 22
2012
Estimate

Drug Iminoral

Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily

Drug Neoral

Neoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily

1 Experimental

taking Iminoral

2 Active Comparator

taking Neoral

Criteria 

Inclusion Criteria:

renal transplantation candidates
written consent
not taking participate in any other clinical trial in last 3 months

Exclusion Criteria:

primary FSGS
hyperoxaluria
age under 18
multi organ transplantation
any malignancy in 5 years
PRA > 25%
use of Tacrolimus
hyper acute rejection
No Results Posted