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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00656695

Enrollment

208

Registered

2008-04-11

Start date

2008-04-30

Completion date

2009-10-31

Last updated

2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Renal Transplantation

Keywords

Iminoral, Neoral, Acute renal transplant rejection

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.

Interventions

DRUGIminoral

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

DRUGNeoral

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
transplanted kidney acute rejection	one year

Secondary

Measure	Time frame
cyclosporine side effects	one year

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026