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:60 eligible patients who recently have kidney transplant from Imam Reza hospital of Kermanshah have been included in the study gradually during 4 months and follow up for 6 months. Qualified Participants:60 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; Episodes of Acute Renal rejection;Dialysis necessary;Presence of side effects,Patient situation(dead,alive).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072118548N1
Registration date:2014-08-19, 1393/05/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-19, 1393/05/28
Registrant information
Name
Hamed Mohamadian Shoeili
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6325
Email address
h_mohamadian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University Of Medical Sciences,
Expected recruitment start date
2014-04-25, 1393/02/05
Expected recruitment end date
2014-08-27, 1393/06/05
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; 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
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti.Blv,
City
Kermanshah
Postal code
Approval date
2013-12-17, 1392/09/26
Ethics committee reference number
50646
Health conditions studied
1
Description of health condition studied
Comparative Interventional Treatment for reduceing the renal transplant rejection
ICD-10 code
T86.1
ICD-10 code description
kidney transplant rejection
Primary outcomes
1
Description
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 outcomes
1
Description
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)
2
Description
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
3
Description
Presence of Adverse events
Timepoint
During 6 months after transplant(at week 3,4,6,8,10,12,16,20,24)
During 6 months after transplant(at week 3,4,6,8,10,12,16,20,24)
Method of measurement
Alive or dead
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Hamed Mohamadian Shoeili
Street address
Imam Reza hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Kermanshah University Of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Shahid Beheshti Blv, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Kermanshah University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hamed Mohamadian Shoeili
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
h_mohamadian@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Daryush Reissi
Position
Nephrologist
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
drreassi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hamed Mohamadian Shoeili
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Imam Reza hospital,
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
h_mohamadian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)