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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammad Reza Khatami, Imam Khomeini Hospital
ClinicalTrials.gov Identifier:
NCT00656695
First received: April 7, 2008
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
End Stage Renal Disease
Renal Transplantation
Drug: Iminoral
Drug: Neoral
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Imam Khomeini Hospital:

Primary Outcome Measures:
  • transplanted kidney acute rejection [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cyclosporine side effects [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 208
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mohammad Reza Khatami, Associate professor, Imam Khomeini Hospital
ClinicalTrials.gov Identifier: NCT00656695     History of Changes
Other Study ID Numbers: iminoral
Study First Received: April 7, 2008
Last Updated: June 21, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Imam Khomeini Hospital:
Iminoral
Neoral
Acute renal transplant rejection

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

ClinicalTrials.gov processed this record on November 25, 2014