IRCT2013012612274N1
Completed
Phase 3
Evaluation of the Clinical safety and efficacy of Suprimun compared with Cellcept in renal transplant recipients
Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Comparative Interventional Treatment for reduceing the renal transplant rejection.
- Sponsor
- Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •Have signed the informed consent form; Have a BMI (body mass index) between 18\.5 and 24\.9; Are male or females between the age of 18 and 60years old; Are going to be transplanted (kidney) for the first time; Are willing to begin and continue treatment with the triple scheme (corticosteroids, cyclosporine and Suprimun/Cellcept®); Are going to benefit from this triple scheme; Are in good general medical conditions; Agree to use birth control methods; Have ABO compatibility; Have low immunologic risk (PRA \< 20%, high HLA compatibility); Are taking MMF with a total dose of 2 gr/d (4 tablets); Are receiving transplant from non\-relative and alive donors.
- •Exclusion Criteria :
- •Receive Mycophenolate Mofetil from another brandname; Have active Hepatitis B or C; Is intolerant to any of the drugs of the triple scheme; Have any medical condition that can interfere with the normal follow up of the study; Has a history of MI, life\-threatening arrhythmia or CVA in the last 6 month , history of malignancy, pregnancy and breastfeeding; Have participated in another clinical study 3 months ago or less before the selection visit; Any induction Therapy (ATG , IL2 receptor inhibitor) before or during the surgery; Any renal rejection with non\-relative reason to Mycophenolate drug during 48h after the surgery.(Vascular rejection, urological rejection); Taking medications that interfere with the action of the drug, including: Magnesium and Aluminum Hydroxide, Cholestyramine, phenytoin , diltiazem and Probenecid, any live vaccines; Are being transplanted for 2nd or 3rd time, or from cadaver; Be addicted to alcohol or illegal drugs;Be HIV positive
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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