A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
- Conditions
- End-stage Renal Disease
- Interventions
- Biological: Rabbit Anti-thymocyte Immunoglobulin
- Registration Number
- NCT03099122
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Thymoglobuline Rabbit Anti-thymocyte Immunoglobulin 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. Thymoglobuline Mycophenolate Na 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. Thymoglobuline Tacrolimus 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. Thymoglobuline Mycophenolate mofetil 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. Thymoglobuline prednisone 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. Thymoglobuline Methylprednisolone 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.
- Primary Outcome Measures
Name Time Method Percentage of patients with biopsy-proven acute rejection events 6 months
- Secondary Outcome Measures
Name Time Method Percentage of acute rejection events in different risk stratifications 6 months Percentage of delayed graft function events in different risk stratifications 6 months Assessment of delayed graft function risk factors 6 months 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
Trial Locations
- Locations (1)
CHINA
🇨🇳China, China