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

NCT00656695 | Completed Phase 4 DMC

• 1 other identifier: iminoral
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Renal Transplantation

Keywords

Iminoral; Neoral; Acute renal transplant rejection

Outcome Measures

Primary Outcomes (1)

• transplanted kidney acute rejection

  one year

Secondary Outcomes (1)

• cyclosporine side effects

  one year

Study Arms (2)

1

EXPERIMENTAL

taking Iminoral

Drug: Iminoral

2

ACTIVE COMPARATOR

taking Neoral

Drug: Neoral

Interventions

Iminoral DRUG

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

1

Neoral DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• renal transplantation candidates
• written consent
• not taking participate in any other clinical trial in last 3 months

You may not qualify if:

• primary FSGS
• hyperoxaluria
• age under 18
• multi organ transplantation
• any malignancy in 5 years
• PRA \> 25%
• use of Tacrolimus
• hyper acute rejection

Sponsors & Collaborators

• Imam Khomeini Hospital: lead

Study Sites (1)

Imam Khomeini Hospital

Tehran, Iran

Location

Related Publications (1)

• 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.

  PMID: 26086833 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Iminoral; Cyclosporine

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mohammad R Khatami, MD

  Imam Khomeini Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

IR (1)