Objectives: Evaluation of the Clinical safety and efficacy of Suprimun compared with Cellcept in renal transplant recipients.
Design:Balanced block parallel Randomization control trial study.
Setting and Conduct:100 qualified patients who recently have kidney transplant from 4 clinical sites have been included in the study gradually during 4 months and follow up for 6 months.
Qualified Participants:100 kidney transplanted patients
Intervention: Use of Suprimun (Group A)and Cellcept (Group B) in those transplanted patients who received the triple scheme consisting of Corticosteroids, Cyclosporine and Suprimun/Cellcept from the beginning and follow up for 6 months after surgery.
Main outcome measures(variables): GFR measurement(at weeks 2,6 months after surgery) ; Episodes of Acute Renal rejection;Dialysis necessary;Presence of side effects,Patient situation(dead,alive).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012612274N1
Registration date:2014-03-25, 1393/01/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-25, 1393/01/05
Registrant information
Name
Sepideh Shakeri
Name of organization / entity
Actoverco
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 8479
Email address
sepideh.shakeri@actoverco.com
Recruitment status
Recruitment complete
Funding source
Actover pharmaceutical company
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Clinical safety and efficacy of Suprimun compared with Cellcept in renal transplant recipients
Public title
Evaluation of the Clinical Safety and Efficacy of Suprimun in Renal Transplant Recipients
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Evaluation of the clinical safety and efficacy of Suprimun compared with Cellcept in renal transplant recipients
Secondary trial Id
AS4/910606/118
Registration date
2012-08-27, 1391/06/06
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commetee of Shahid Beheshti Medical University,Urology Research Center
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.
Category
Treatment - Drugs
2
Description
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.