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A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant

NCT03099122 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2022-04-25

No results posted yet for this study

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.

Conditions

  • End-stage Renal Disease

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2019-11-12
Completion
2019-11-12

Countries

  • China

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03099122 on ClinicalTrials.gov