A Phase 4 interventional study of Iminoral and Neoral in End Stage Renal Disease and Renal Transplantation, sponsored by Imam Khomeini Hospital. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-22.
Sponsored by Imam Khomeini Hospital · Phase 4, Interventional, and Treatment
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 208 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Imam Khomeini Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
taking Iminoral
Drug: Iminoral
taking Neoral
Drug: Neoral
Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
Neoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
transplanted kidney acute rejection
Time frame: one year
cyclosporine side effects
Time frame: one year
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Imam Khomeini Hospital