Comparison Between Clinical and Paraclinical Effect of Iminoral Vs Neoral in Prevention of Acute Rejection in Renal Transplantation - Full Text View

Sponsored by:	Imam Khomeini Hospital
Information provided by:	Imam Khomeini Hospital
ClinicalTrials.gov Identifier:	NCT00656695

Purpose

Cyclosporine is the key drug in organ transplantation. In Iran we 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)). Our study is the first clinical trial to compare the effect of Iminoral Vs. 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 Kidney Transplantation	Drug: Iminoral Drug: Neoral	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporin Cyclosporine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	200
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656695

Contacts

Contact: Mohammad Reza Khatami, MD

98-21-6119-2659

khatami@hbi.ir

Locations

Iran, Islamic Republic of
Imam Khomeini Hospital	Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohammad Reza Khatami, MD 00982161192659 khatami@hbi.ir
Sub-Investigator: shahram Taheri, Md
Sub-Investigator: sepideh seifi, MD
Sub-Investigator: farokhlegha ahmadi, MD
Sub-Investigator: mohammad Reza Abbasi, MD
Sub-Investigator: Fatemeh Nazemian, MD
Sub-Investigator: Shiva Seirafian, MD
Sub-Investigator: Effat Razeghi, MD
Sub-Investigator: Mitra Mahdavimazdeh, MD
Sub-Investigator: Jalal Azmandian, MD
Sub-Investigator: Reza Afshar, MD
Sub-Investigator: Masih Naghibi, MD
Sub-Investigator: Shahrzad Shahidi, MD
Sub-Investigator: Mojgan Mortazavi, MD
Sub-Investigator: Abbas Etminan, MD
Sub-Investigator: Mohammad Sayyah, PhD
Sub-Investigator: Simindokht Habibzadeh, MD
Sub-Investigator: Abdolamir Atapoor, MD
Sub-Investigator: Mohammad mehdi Sagheb, MD
Sub-Investigator: Farzaneh Sadri, BA
Principal Investigator: Mohammad R Khatami, MD

Sponsors and Collaborators

Imam Khomeini Hospital

Investigators

Principal Investigator:

Mohammad R Khatami, MD

Imam Khomeini Hospital

More Information

Responsible Party:	Tehran University of Medical Sciences ( Mohammad Reza Khatami MD, associate professor of nephrology )
Study ID Numbers:	iminoral
Study First Received:	April 7, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00656695
Health Authority:	Iran: Ethics Committee

Keywords provided by Imam Khomeini Hospital:

Iminoral
Neoral
Acute renal transplant rejection

Study placed in the following topic categories:

Renal Insufficiency
Cyclosporine
Urologic Diseases
Clotrimazole
Renal Insufficiency, Chronic
Miconazole

Tioconazole
Kidney Failure, Chronic
Kidney Diseases
Cyclosporins
Kidney Failure

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009