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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656695
• Other study ID #: iminoral
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2008
• Last updated: June 21, 2012
• Start date: April 2008
• Est. completion date: October 2009

Study information

• Verified date: June 2012
• Source: Imam Khomeini Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Renal Transplantation

Intervention

Drug:
• Iminoral
Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
• Neoral
Neoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Imam Khomeini Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transplanted kidney acute rejection		one year	Yes
Secondary	cyclosporine side effects		one year	Yes