NCT00656695

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Imam Khomeini Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• End Stage Renal Disease
• Renal Transplantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-04-01
• Completion: 2009-10-01
• First posted: 2008-04-11
• Last updated: 2012-06-22

Locations

1 site across 1 country: Iran