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

Primary Purpose

End Stage Renal Disease, Renal Transplantation

Status

Completed

Phase

Phase 4

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Iminoral

Neoral

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Iminoral, Neoral, Acute renal transplant rejection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Imam Khomeini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

taking Iminoral

taking Neoral

Outcomes

Primary Outcome Measures

transplanted kidney acute rejection

Secondary Outcome Measures

cyclosporine side effects

Full Information

NCT ID

NCT00656695

First Posted

April 7, 2008

Last Updated

June 21, 2012

Sponsor

Imam Khomeini Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00656695

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Imam Khomeini Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease, Renal Transplantation

Keywords

Iminoral, Neoral, Acute renal transplant rejection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

taking Iminoral

Arm Title

Arm Type

Active Comparator

Arm Description

taking Neoral

Intervention Type

Drug

Intervention Name(s)

Iminoral

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Neoral

Intervention Description

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

Primary Outcome Measure Information:

Title

transplanted kidney acute rejection

Time Frame

one year

Secondary Outcome Measure Information:

Title

cyclosporine side effects

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad R Khatami, MD

Organizational Affiliation

Imam Khomeini Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Imam Khomeini Hospital

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26086833

Citation

Khatami SM, Taheri S, Azmandian J, Sagheb MM, Nazemian F, Razeghi E, Shahidi S, Sadri F, Shamshiri AR, Sayyah M. One-Year Multicenter Double-Blind Randomized Clinical Trial on the Efficacy and Safety of Generic Cyclosporine (Iminoral) in De Novo Kidney Transplant Recipients. Exp Clin Transplant. 2015 Jun;13(3):233-8.

Results Reference

derived

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

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