A post-marketing surveillance for the Evaluation of the safety of TGlobulin25 for the induction of immunosuppressive therapy in adult kidney transplant candidates

Phase 4

Conditions: kidney transplantation.
Kidney transplant status
Z94.0

Registration Number: IRCT20201230049888N1

Lead Sponsor: Kawsar biotech company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.