Trials / Completed
CompletedNCT03099122
A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rabbit Anti-thymocyte Immunoglobulin | Pharmaceutical form: creamy-white powder Route of administration: intravenous |
| DRUG | Tacrolimus | Pharmaceutical form: tablet Route of administration: oral |
| DRUG | Methylprednisolone | Pharmaceutical form: powder Route of administration: intravenous |
| DRUG | Mycophenolate mofetil | Pharmaceutical form: capsule Route of administration: oral |
| DRUG | Mycophenolate Na | Pharmaceutical form: capsule Route of administration: oral |
| DRUG | prednisone | Pharmaceutical form: tablet Route of administration: oral |
Timeline
- Start date
- 2017-08-16
- Primary completion
- 2019-11-12
- Completion
- 2019-11-12
- First posted
- 2017-04-04
- Last updated
- 2022-04-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03099122. Inclusion in this directory is not an endorsement.