Safety and efficacy of Anti-Thymocyte Glubolin (Zist Kowsar Pharmaceutical Company) in comparison with Anti-Thymocite Glubolin (Genzyme) for immunisuppressive induction therapy in adults with renal transplantayion: A phase III, randomized, parallel, single blind , non inferiority design
Determing safety and efficacy of Anti-Thymocyte Glubolin (Kowsar biotech Company) in comparison with Anti-Thymocite Glubolin (Genzyme) for immunisuppressive induction therapy in adults with renal transplantation
Design
Randomized controlled trial, parallel, single blind with sample size of 129
Settings and conduct
129 renal transplant candidates who are blinded to intervention groups are randomly assigned to one group and receive one brand of thymoglobulin in addition to other equal routine drug regimen
Participants/Inclusion and exclusion criteria
Inclusion criteria: recipient age>18 yrs, willingness to sign the informed consent, PRA+, Second graft, Delayed onset of graft function, reception from cadaver graft
Exclusion criteria: Positive history of polyclonal Anti-T-Cell therapy, Known allergy to rabbit proteins, positive history of malignancy in 2 years
Pregnancy or Lactation, willingness to pregnancy and not using a safe contraceptive method, positive serology for HTLV, HIV or HBV
Intervention groups
Two intervention groups: one group receives thymoglobulin (KBC) and the other group receives thymoglobulin (Genzyme )
Main outcome variables
Any adverse drug outcome and reaction, graft rejection, patient survival, graft survival, incidence of infection, serious adverse events
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003200N6
Registration date:2019-01-15, 1397/10/25
Registration timing:prospective
Last update:2019-01-15, 1397/10/25
Update count:3
Registration date
2019-01-15, 1397/10/25
Registrant information
Name
Kazem Heidari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6649 5948
Email address
k_heidari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of Anti-Thymocyte Glubolin (Zist Kowsar Pharmaceutical Company) in comparison with Anti-Thymocite Glubolin (Genzyme) for immunisuppressive induction therapy in adults with renal transplantayion: A phase III, randomized, parallel, single blind , non inferiority design
Public title
Safety and efficacy of Anti-Thymocyte Glubolin (Zist Kowsar Pharmaceutical Company) in comparison with Anti-Thymocite Glubolin (Genzyme) for immunisuppressive induction therapy in adults with renal transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age >18 yrs for recipient
ability and willingness to sign the informed consent
PRA+ (Panel Reactive Antibody)
second graft (already rejected a kidney moe than 6-12 month ago)
DGF (Delayed onset of graft function)
Reception of kidney from cadaver
Exclusion criteria:
Positive history of polyclonal Anti-T-Cell therapy
Known allergy to Rabbit proteins
Positive history of malignancy in 2 years( excluding stem cell , squamous cell, bladder malignancies and asymptomatic invasive papillary renal cell cancer with less than 5 cm size)
Pregnancy
Lactating mother
Willingness to pregnancy and not using a safe contraceptive method
Positive serology for: HTLV, HIV or HBV
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
129
Randomization (investigator's opinion)
Randomized
Randomization description
random sequence for patients are made online using "sealed envelope" website.Randomized blocks are constructed for 129 patients. Codes are labelled on investigational drugs. after including each patient, site nurse calls the medical unit of company and receives the proper randomization code assigned to a special drug.
Blinding (investigator's opinion)
Single blinded
Blinding description
Drug packages are similar and labelled for investigational use. Patients are blinded to assigned therapy (active or standard drug) and group.
Placebo
Not used
Assignment
Parallel
Other design features
Relation of sample size for reference drug to test drug is 1:1.33
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods street
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.TUMS.VCR.REC.1397.722
Health conditions studied
1
Description of health condition studied
Renal transplatation
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Any adverse reaction
Timepoint
Anytime after intervention
Method of measurement
clinical or laboratory data
2
Description
Graft rejection
Timepoint
after 6 months
Method of measurement
Investigator documentation during follow-up
3
Description
Patient death/survival
Timepoint
After graft to end of follow up
Method of measurement
Investigator documentation during follow-up
4
Description
Graft loss
Timepoint
After graft to end of follow up
Method of measurement
Investigator documentation during follow-up
5
Description
incidence of infection (especially CMV)
Timepoint
After graft to end of follow up
Method of measurement
Periodic Lab data during follow up
6
Description
Serious adverse events
Timepoint
After graft to end of follow up
Method of measurement
Investigator documentation during follow-up
Secondary outcomes
1
Description
Delayed graft function (DGF)
Timepoint
During the first 7 days after transplantation
Method of measurement
Having dialysis during the first 7 days after transplantation
2
Description
Hospitalization time after transplantation
Timepoint
Graft to discharge time
Method of measurement
Hospital records
3
Description
T-cell lymphocyte count
Timepoint
Before and after drug injection
Method of measurement
Lab data: Complete blood count
Intervention groups
1
Description
Intervention group: 1- TGlobulin (Kowsar biotech Co.): 1-1.5 mg/kg/d for 4 days 2- cellcept 1gr/stat then 1gr/BD or Myfortic 750 mg/stat then 750mg/BD 3- Tacrolimus capsule 1mg/kg/stat then 0.07 mg/kg/d 4- Steroid 1gr/stat then 1mg/kg/d
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: 1- Thymoglobulin (Genzyme): 1-1.5 mg/kg/d for 4 days 2- cellcept 1gr/stat then 1gr/BD or Myfortic 750 mg/stat then 750mg/BD 3- Tacrolimus capsule 1mg/kg/stat then 0.07 mg/kg/d 4- Steroid 1gr/stat then 1mg/kg/d
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Gholamhossein Naderi
Street address
North Kargar street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
gh_naderi2000@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kowsar Biotechnology company
Full name of responsible person
Siroos Zeinali
Street address
N0 41, Majlesi st., Valiasr Street
City
Tehran
Province
Tehran
Postal code
1595645513
Phone
+98 21 8893 9150
Fax
+98 21 8893 9139
Email
zeinali@gmail.com
Web page address
http://kawsarbiotech.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kowsar Biotechnology company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Pasture Institute of Iran
Full name of responsible person
Mehdi Behdani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No 41, Majlesi St., Valiasr street
City
Tehran
Province
Tehran
Postal code
1595645513
Phone
+98 21 6648 0780
Email
behdani73042@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Gholamhossein Naderi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
North Kargar street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
gh_naderi2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kazem Heidari
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
16th Azar street, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417993337
Phone
+98 21 8896 3546
Fax
+98 21 8896 3546
Email
k_heidari@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of confidentiality and regulatory limitation
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available