Comparative Interventional Treatment for reduceing the renal transplant rejection. kidney transplant rejection
Conditions
Interventions
Intervention 1: Group A(Intervention): They get Suprimun tab which is contained 500 mg mycophenolate mofetil.The total dose is 2gr per day which was used 1gr twice a day before meal. Intervention 2: G
Treatment - Drugs
Group A(Intervention): They get Suprimun tab which is contained 500 mg mycophenolate mofetil.The total dose is 2gr per day which was used 1gr twice a day before meal.
Group B(control): They get Cellcept capsule which is contained 500 mg Mychophenolate mofetil.The total dose is 2gr per day which was used 1gr twice a day before meal.
Sponsors
Research Deputy of Kermanshah University Of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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: During 6 months after transplant(at week 3,4,6,8,10,12,16,20,24).;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.;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.;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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamed Mohamadian Shoeili
Kermanshah University of Medical Sciences
Outcome results
None listed