Comparisone of Iminoral Versus Neoral in Prevention of Ac... | NCT00656695

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

NCT00656695

Sponsor

Imam Khomeini Hospital

Status

Completed

Last Update Posted

Jun 22, 2012Estimated

Enrollment

208Actual

Phase

Phase 4

Conditions

End Stage Renal Disease
Renal Transplantation

Interventions

Iminoral
Neoral

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Apr 7, 2008

First Submission Date that Met QC Criteria

Apr 7, 2008

First Posted Date

Apr 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2012

Last Update Posted Date

Jun 22, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	taking Iminoral	Drug: Iminoral
2	Active Comparator	taking Neoral	Drug: Neoral

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iminoral	Drug	Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily	1

Measure	Description	Time Frame
transplanted kidney acute rejection		one year

Measure	Description	Time Frame
cyclosporine side effects		one year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammad R Khatami, MD	Imam Khomeini Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imam Khomeini Hospital		Tehran			Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26086833	Derived	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.

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds