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

Imam Khomeini Hospital

Status and phase: Completed; Phase 4

Conditions: End Stage Renal Disease; Renal Transplantation

Treatments: Drug: Neoral; Drug: Iminoral

Study type: Interventional

Funder types: Other

Identifiers

NCT00656695

iminoral

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups

1

Experimental group

Description:

taking Iminoral

Treatment:

Drug: Iminoral

2

Active Comparator group

Description:

taking Neoral

Treatment:

Drug: Neoral