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Clinical Trials/IRCT2014072118548N1
IRCT2014072118548N1
Completed
Phase 3

Evaluation of the Clinical safety and efficacy of Suprimun compared with Cellcept in renal transplant recipients

Research Deputy of Kermanshah University Of Medical Sciences0 sites60 target enrollmentTBD
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ConditionsComparative Interventional Treatment for reduceing the renal transplant rejection.kidney transplant rejection

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Comparative Interventional Treatment for reduceing the renal transplant rejection.
Sponsor
Research Deputy of Kermanshah University Of Medical Sciences
Enrollment
60
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Research Deputy of Kermanshah University Of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • •Inclusion Criteria: Have signed the informed consent form; Are male or females between the age of 18 and 55 years 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; 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); 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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