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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201230049888N1

Enrollment

100

Registered

2022-11-09

Start date

2022-11-22

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney transplantation. Kidney transplant status

Interventions

Intervention group: Patients receiving 5-6 mg/kg total dose of Tglobulin 25 for 4 days according to the actual body weight.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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 4 ischemic time> 4 hours

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnaz Hedayatjoo

ArtaZist Pharmed Co

b.hedayatjoo@artapharmed.com+98 21 8609 2503

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026