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IRCT20201230049888N1 IRCT 2022-11-09 Kawsar biotech company A post-marketing surveillance for the Evaluation of the safety of TGlobulin25 for the induction of immunosuppressive therapy in adult kidney transplant candidates A post-marketing surveillance for the Evaluation of the safety of TGlobulin25 (manufactured by KBC) for the induction of immunosuppressive therapy in adult kidney transplant candidates 2022-11-22 anticipated 100 Complete https://irct.ir/trial/65436 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 4 kidney transplantation. Intervention group: Patients receiving 5-6 mg/kg total dose of Tglobulin 25 for 4 days according to the actual body weight. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Behnaz Hedayatjoo
ArtaZist Pharmed Co, Tehran, Sheikh Bahaiee, Rayan Vanak, 603
Tehran Iran (Islamic Republic of) 1993873057 +98 21 8609 2503 b.hedayatjoo@artapharmed.com ArtaZist Pharmed Co scientific Mojtaba Shafiekhani
Sadra, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 71994-67985 +98 71 3344 0000 mojtabashafiekhani@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Kidney transplant candidate patients referred to Abuali sina hospital in shiraz, receiving Tglobulin 25 for induction of immunosuppressive therapy. The age of the transplant recipient should be more than 18 years and less than 65 years, and the donor should be more than 5 years and less than 60 years. Able to understand the study and sign the written informed consent 18 years 65 years Both History of previous treatment with anti-T cell polyclonal agents Panel-Reactive Antibody (PRA)> 20% Known allergy to rabbit proteins Evidence of malignancy in the past 2 years pregnant or lactating females Patients with serological evidence of HIV, HTLV, HCV, HBV WBC< 2000 and/or Plt< 50000 when receiving Tglobulin 25 patients receiving organs other than kidney candidates of second kidney transplant donor Serum creatinine> 4 ischemic time> 4 hours Z94.0 Kidney transplant status Treatment - Drugs Intervention group: Patients receiving 5-6 mg/kg total dose of Tglobulin 25 for 4 days according to the actual body weight Delayed graft function. Timepoint: All along the study duration until one year after transplantation surgery. Method of measurement: kidney transplant rejection approved by biopsy or clinical symptoms and laboratory tests. Mortality. Timepoint: End of 52 weeks. Method of measurement: living status of the patient. Adverse effects. Timepoint: throughout the 52 weeks. Method of measurement: patients self report, clinical symptoms, and laboratory data. Acute rejection. Timepoint: daily up to 14 days. Method of measurement: clinical symptoms such as creatinine rise, and final diagnosis based on histopathology. Chronic rejection. Timepoint: monthly up to 12 months. Method of measurement: clinical symptoms such as creatinine rise, and final diagnosis based on histopathology. Kawsar biotech company Approved 2022-06-22 کمیته اخلاق دانشگاه علوم پزشکی شیراز Secretariat of the Research Ethics Committee of the University, Research and Technology Vice-Chancellor, 7th Floor, Central Building, Shiraz University of Medical Sciences, Zand St, Shiraz شیراز Fars Iran (Islamic Republic of)