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 we 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)). Our study is the first clinical trial to compare the effect of Iminoral Vs. Neoral in preventing acute rejection in renal transplantation and also to compare the side effects of these two drugs.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Primary Measures

• transplanted kidney acute rejection
  • Time Frame: one year
    Safety Issue?: Yes

Secondary Measures

• cyclosporine side effects
  • Time Frame: one year
    Safety Issue?: Yes

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

Lead Sponsor: Imam Khomeini Hospital

Overall Clinical Trial Officials and Contacts

Mohammad R Khatami, MD Principal Investigator Imam Khomeini Hospital  

Overall Contact: Mohammad Reza Khatami, MD 98-21-6119-2659 khatami@hbi.ir

Information obtained from ClinicalTrials.gov on November 20, 2008

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