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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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1

taking Iminoral

Group Type EXPERIMENTAL

Iminoral

Intervention Type DRUG

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

2

taking Neoral

Group Type ACTIVE_COMPARATOR

Neoral

Intervention Type DRUG

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

Interventions

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Iminoral

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

Intervention Type DRUG

Neoral

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No