Comparisone of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imam Khomeini Hospital
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

1. renal transplantation candidates

2. written consent

3. not taking participate in any other clinical trial in last 3 months

Exclusion Criteria:

1. primary FSGS

2. hyperoxaluria

3. age under 18

4. multi organ transplantation

5. any malignancy in 5 years

6. PRA > 25%

7. use of Tacrolimus

8. hyper acute rejection