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NCT Number: NCT00656695

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

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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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Renal Transplantation Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Imam Khomeini Hospital

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • renal transplantation candidates
  • written consent
  • not taking participate in any other clinical trial in last 3 months

Exclusion criteria

  • primary FSGS
  • hyperoxaluria
  • age under 18
  • multi organ transplantation
  • any malignancy in 5 years
  • PRA > 25%
  • use of Tacrolimus
  • hyper acute rejection

Treatment and study plan

Iminoral

Drug

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

Neoral

Drug

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

Primary outcomes

  1. transplanted kidney acute rejection

    Time frame: one year

Secondary outcomes

  1. cyclosporine side effects

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Imam Khomeini Hospital

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 11, 2008
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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