A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Percentage of patients with biopsy-proven acute rejection events
Overview
Brief Summary
Primary Objective:
To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney transplant.
Secondary Objectives:
- To evaluate delayed graft function (DGF), graft and patient survival after kidney transplant.
- To evaluate adverse events of Thymoglobuline® throughout the study.
- To explore possible risk factors of AR and DGF in patients with DCD kidney transplant.
- To evaluate AR and DGF under different risk stratifications and explore an description optimal induction therapy regimen for recipients of DCD kidney transplant.
Detailed Description
The total study duration per patient is 6.5 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Thymoglobuline
A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice.
Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies.
Intervention: Rabbit Anti-thymocyte Immunoglobulin (Biological)
Thymoglobuline
A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice.
Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies.
Intervention: Tacrolimus (Drug)
Thymoglobuline
A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice.
Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies.
Intervention: Methylprednisolone (Drug)
Thymoglobuline
A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice.
Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies.
Intervention: Mycophenolate mofetil (Drug)
Thymoglobuline
A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice.
Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies.
Intervention: Mycophenolate Na (Drug)
Thymoglobuline
A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice.
Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies.
Intervention: prednisone (Drug)
Outcomes
Primary Outcomes
Percentage of patients with biopsy-proven acute rejection events
Time Frame: 6 months
Secondary Outcomes
- Percentage of survived patients(6 months)
- Percentage of delayed graft function events(6 months)
- Duration of delayed graft function events(6 months)
- Percentage of survived grafts(6 months)
- Assessment of acute rejection risk factors(6 months)
- Assessment of delayed graft function risk factors(6 months)
- Percentage of acute rejection events in different risk stratifications(6 months)
- Percentage of delayed graft function events in different risk stratifications(6 months)