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

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ClinicalTrials.gov Identifier: NCT00656695
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):
Mohammad Reza Khatami, Imam Khomeini Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Renal Transplantation Drug: Iminoral Drug: Neoral Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
taking Iminoral
Drug: Iminoral
Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
Active Comparator: 2
taking Neoral
Drug: Neoral
Neoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily



Primary Outcome Measures :
  1. transplanted kidney acute rejection [ Time Frame: one year ]

Secondary Outcome Measures :
  1. cyclosporine side effects [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656695


Locations
Iran, Islamic Republic of
Imam Khomeini Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Imam Khomeini Hospital
Investigators
Principal Investigator: Mohammad R Khatami, MD Imam Khomeini Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mohammad Reza Khatami, Associate professor, Imam Khomeini Hospital
ClinicalTrials.gov Identifier: NCT00656695     History of Changes
Other Study ID Numbers: iminoral
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Mohammad Reza Khatami, Imam Khomeini Hospital:
Iminoral
Neoral
Acute renal transplant rejection

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cyclosporine
Cyclosporins
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Calcineurin Inhibitors