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Study on the therapeutic effect and safety of anti human T cell pig immunoglobulin induced kidney transplantation therapy

Study on the therapeutic effect and safety of anti human T cell pig immunoglobulin induced kidney transplantation therapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086400
Enrollment
Unknown
Registered
2024-07-01
Start date
2023-11-18
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

kidney transplantation

Interventions

p-ATG:On the day of surgery and the 1st, 2nd, 3rd, and 4th day after surgery, respectively
2 bottles of p-ATG each time
Basiliximab:On the day of surgery and the 4th day after surgery, respectively
1 bottle of Basiliximab each time

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Subjects with end-stage renal disease and suitable for first-time DCD kidney transplantation; 2) Male or female participants (Chinese residents) aged between 18 and 65 years (inclusive); 3) Kidney transplant recipients who plan to receive ABO blood type matching; 4) The peak of group reactive antibody (PRA) is less than 10% or the test result is negative; 5) Voluntary signing of informed consent form; 6) Immunosuppressive therapy based on calcineurin inhibitors (CNIs), mycophenolate mofetil (MMF), and prednisone.

Exclusion criteria

Exclusion criteria: (1) Individuals who are severely allergic to the test drug and unable to use it; (2) White blood cell count2 times the upper limit of normal (ULN); (11) Poor compliance or other situations that are not suitable for research.

Design outcomes

Primary

MeasureTime frame
The incidence, timing, and histological severity of AR within 6 months after transplantation;

Secondary

MeasureTime frame
Lymphocyte classification and function;The incidence and duration of delayed recovery of graft function;Changes in renal function;Patient and transplant kidney survival rate;The incidence of AE/ASE;

Countries

China

Contacts

Public ContactXiaoming Ding

The First Affiliated Hospital of Xi'an Jiaotong University

xmding@mail.xjtu.edu.cn+86 139 9123 8632

Outcome results

None listed

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