Comparison Between Clinical and Paraclinical Effect of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation
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...
Brief Summary
Official Title: “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”
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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: April 2009
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- taking Iminoral
- Active Comparator: 2
- taking Neoral
Outcome Measures for this Clinical Trial
Primary Measures
- transplanted kidney acute rejection
- Time Frame: one year
Safety Issue?: Yes
- Time Frame: one year
Secondary Measures
- cyclosporine side effects
- Time Frame: one year
Safety Issue?: Yes
- Time Frame: one year
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Imam Khomeini Hospital Other
Overall Clinical Trial Officials and Contacts
Mohammad R Khatami, MD Principal Investigator Imam Khomeini Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00656695
Study ID Number: iminoral
ClinicalTrials.gov Identifier: NCT00656695
Health Authority: Iran: Ethics Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00656695
