IRCT20201230049888N1Not yet recruitingPhase 4
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
Kawsar biotech company0 sites100 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 65 years (—)
- Sex
- All
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
Investigators
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