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IRCT20100127003200N6 IRCT 2019-01-15 Kowsar Biotechnology company 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 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 2019-02-20 anticipated 129 Complete https://irct.ir/trial/35958 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Relation of sample size for reference drug to test drug is 1:1.33, 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 description: Drug packages are similar and labelled for investigational use. Patients are blinded to assigned therapy (active or standard drug) and group. 3 Renal transplantation. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of confidentiality and regulatory limitation
public Mehdi Behdani
No 41, Majlesi St., Valiasr street
Tehran Iran (Islamic Republic of) 1595645513 +98 21 6648 0780 behdani73042@yahoo.com Pasture Institute of Iran scientific Monir-Sadat Hakemi
North Kargar street
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 mhakemi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both 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 Z94.0 Kidney transplant status Treatment - Drugs Treatment - Drugs 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 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 Any adverse reaction. Timepoint: Any time after intervention. Method of measurement: Clinical or laboratory data. Graft rejection. Timepoint: After 6 months. Method of measurement: Investigator documentation during follow-up. Patient death/survival. Timepoint: After graft to end of follow up. Method of measurement: Investigator documentation during follow-up. Graft loss. Timepoint: After graft to end of follow up. Method of measurement: Investigator documentation during follow-up. Incidence of infection (especially CMV). Timepoint: After graft to end of follow up. Method of measurement: Periodic Lab data during follow up. Serious adverse events. Timepoint: After graft to end of follow up. Method of measurement: Investigator documentation during follow-up. Delayed graft function (DGF). Timepoint: During the first 7 days after transplantation. Method of measurement: Having dialysis during the first 7 days after transplantation. Hospitalization time after transplantation. Timepoint: Graft to discharge time. Method of measurement: Hospital records. T-cell lymphocyte count. Timepoint: Before and after drug injection. Method of measurement: Lab data: Complete blood count. Kowsar Biotechnology company Approved 2019-01-06 Ethics committee of Tehran University of Medical Sciences Qods street Tehran Tehran Iran (Islamic Republic of)