Evaluation of the Clinical Safety and Efficacy of Suprimun in Renal Transplant Recipients
- Conditions
- Comparative Interventional Treatment for reduceing the renal transplant rejection.kidney transplant rejection
- Registration Number
- IRCT2013012612274N1
- Lead Sponsor
- Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glomerular Filtration Rate(GFR). Timepoint: During 6 months after transplant(at week 2,6th month). Method of measurement: Plasma Creatinine,Age & weight and gender of patient.
- Secondary Outcome Measures
Name Time Method Dialysis requirement due to nephrologist decision. Timepoint: During 6 months after transplant(at week 3,4,6,8,10,12,16,20,24). Method of measurement: Rises of Plasma Creatinine.;Incidence of acute renal rejection. Timepoint: During 6 months after transplant(at week 3,4,6,8,10,12,16,20,24). Method of measurement: Renal Biopsy.;Situation of the patients. Timepoint: During 6 months after transplant(at week 3,4,6,8,10,12,16,20,24). Method of measurement: Alive or dead.;Presence of Adverse events. Timepoint: During 6 months after transplant(at week 3,4,6,8,10,12,16,20,24). Method of measurement: Leukopenia,thrombocytopenia,gastrointestinal discomfort,malignancy,viral infections.