Protocol summary
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Study aim
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Determining safety and efficacy of Anti-Thymocyte Globulin (Kowsar biotech Company) in comparison with Anti-Thymocyte Globulin (Genzyme) for immunosuppressive induction therapy in adults with renal transplantation
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Design
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Randomized controlled trial, parallel, single blind with sample size of 129
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: recipient age>=18 years( donor age>=5), willingness to sign the informed consent, renal graft from cadaver, Second graft (patients who had rejected the renal graft once can be enrolled 6-12 months after the rejection), Delayed onset of graft function OR reception from cadaver graft OR indication for receiving the investigated drug 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
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Intervention groups
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Two intervention groups: one group receives thymoglobulin (KBC) and the other group receives thymoglobulin (Genzyme )
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Main outcome variables
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Any adverse drug outcome and reaction, graft rejection, patient survival, graft survival, incidence of infection, serious adverse events
General information
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Reason for update
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َAdding actual sample size reached, actual recruitment start and end date, and trial completion date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100127003200N6
Registration date:
2019-01-15, 1397/10/25
Registration timing:
prospective
Last update:
2025-02-21, 1403/12/03
Update count:
3
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Registration date
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2019-01-15, 1397/10/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-02-20, 1397/12/01
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Expected recruitment end date
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2023-03-20, 1401/12/29
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Actual recruitment start date
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2019-04-26, 1398/02/06
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Actual recruitment end date
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2022-05-10, 1401/02/20
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Trial completion date
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2022-11-19, 1401/08/28
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Scientific title
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Safety and efficacy of Anti-Thymocyte Globulin (Zist Kowsar Pharmaceutical Company) in comparison with Anti-Thymocyte Globulin (Genzyme) for immunosuppressive induction therapy in adults with renal transplantation: A phase III, randomized, parallel, single blind , non-inferiority design
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Public title
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Safety and efficacy of Anti-Thymocyte Globulin (Zist Kowsar Pharmaceutical Company) in comparison with Anti-Thymocyte Globulin (Genzyme) for immunosuppressive induction therapy in adults with renal transplantation
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age >18 years (donor age >= 5) for recipient
ability and willingness to sign the informed consent
Reception of kidney from cadaver OR second graft (already rejected a kidney more than 6-12 month ago) OR indication for receiving the investigated drug
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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
129
Actual sample size reached:
119
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Drug packages are similar and labelled for investigational use. Patients are blinded to assigned therapy (active or standard drug) and group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Relation of sample size for reference drug to test drug is 1:1.33
Ethics committees
1
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Ethics committee
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Approval date
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2019-01-06, 1397/10/16
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Ethics committee reference number
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IR.TUMS.VCR.REC.1397.722
Health conditions studied
1
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Description of health condition studied
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Renal transplantation
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ICD-10 code
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Z94.0
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ICD-10 code description
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Kidney transplant status
Primary outcomes
1
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Description
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Any adverse reaction
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Timepoint
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Any time after intervention
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Method of measurement
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Clinical or laboratory data
2
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Description
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Graft rejection
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Timepoint
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After 6 months
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Method of measurement
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Investigator documentation during follow-up
3
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Description
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Patient death/survival
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Timepoint
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After graft to end of follow up
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Method of measurement
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Investigator documentation during follow-up
4
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Description
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Graft loss
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Timepoint
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After graft to end of follow up
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Method of measurement
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Investigator documentation during follow-up
5
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Description
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incidence of infection (especially CMV)
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Timepoint
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After graft to end of follow up
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Method of measurement
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Periodic Lab data during follow up
6
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Description
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Serious adverse events
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Timepoint
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After graft to end of follow up
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Method of measurement
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Investigator documentation during follow-up
Secondary outcomes
1
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Description
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Delayed graft function (DGF)
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Timepoint
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During the first 7 days after transplantation
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Method of measurement
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Having dialysis during the first 7 days after transplantation
2
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Description
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Hospitalization time after transplantation
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Timepoint
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Graft to discharge time
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Method of measurement
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Hospital records
3
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Description
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T-cell lymphocyte count
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Timepoint
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Before and after drug injection
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Method of measurement
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Lab data: Complete blood count
Intervention groups
1
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Description
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Intervention group 1: 1- TGlobulin (Kowsar biotech Co.): 1-1.5 mg/kg/d for 4 days (Total dose of 3-7 mg/kg for each patient) 2- Cellcept 1gr/stat then 1gr/BD or Myfortic 720 mg/stat then 720 mg/BD 3- Tacrolimus capsule 1mg/kg/stat then 0.07 mg/kg/d 4- Steroid 1gr/stat then 1mg/kg/d
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: 1- Thymoglobulin (Genzyme): 1-1.5 mg/kg/d for 4 days (Total dose of 3-7 mg/kg for each patient) 2- cellcept 1gr/stat then 1gr/BD or Myfortic 720 mg/stat then 720 mg/BD 3- Tacrolimus capsule 1mg/kg/stat then 0.07 mg/kg/d 4- Steroid 1gr/stat then 1mg/kg/d
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kowsar Biotechnology company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Because of confidentiality and regulatory limitation
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available