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

NCT00656695 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2012-06-22

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Imam Khomeini Hospital

    lead OTHER

Principal Investigators

  • Mohammad R Khatami, MD · Imam Khomeini Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-04-30
Completion
2009-10-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00656695 on ClinicalTrials.gov