Overview

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

Status:
Completed
Trial end date:
2019-11-12
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Antibodies
Antilymphocyte Serum
Immunoglobulins
Immunoglobulins, Intravenous
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Tacrolimus
Thymoglobulin
Criteria
Inclusion criteria :

- Male or female.

- Patient is a Chinese recipient of kidney transplant for the first time.

- Patient is a recipient of kidney allograft from Chinese donors donated after cardiac
death (including kidney donated after brain death followed by circulatory death).

- Recipient's age is between 18 to 65 years old (including 18 years).

- Donor's age is more than 5 years old.

- Recipient's weight is greater than or equal to 50 kg but less than or equal to 80 kg.

- Patient fully understands the study and signs the informed consent form (ICF) prior to
any study procedure.

Exclusion criteria:

- Patient is a multiple organ transplant recipient.

- Recipient with previous kidney or other organ transplant history.

- Recipient and donor have incompatible blood types.

- Recipient and donor have 5 or 6 mismatched human leucocyte antigen (HLA).

- Recipient is known to have an active infection or active chronic infection, or is
seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV Ab), or
human immunodeficiency virus (HIV). (Serological test results within 12 months before
transplantation are acceptable.)

- Recipient with cytomegalovirus (CMV) immunoglobulin G (IgG) negative who receives an
allograft from CMV IgG positive donor (CMV IgG [D+/R-]).

- Any systemic infection requiring continuous treatment at enrolment, but prophylactic
treatment of CMV and/or Pneumocystis carinii pneumonia (PCP) is allowed.

- Recipient has severe thrombocytopenia or leucopenia before operation (platelet count
<75,000/ul, or the number of white blood cells <3,000 cells/mm3).

- Serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or
gamma glutamine transferase (GGT) ≥3ULN (upper limit of normal) within 1 week before
transplantation, and not normalized at time of transplantation.

- Recipient has a history of malignancy within 5 years.

- Recipient with history of allergy and anaphylaxes to rabbit proteins or to any
excipients.

- Recipient has known contraindications to the administration of Thymoglobuline®.

- Recipient has taken other investigational drugs or prohibited therapy for this study
within 1 month or 5 of half-lives from screening, whichever is longer.

- Recipient has previously used Thymoglobuline®, or has participated in any clinical
trial of any other medicine or device within 30 days before signing ICF.

- Pregnant or lactating women.

- Male and female patients do not agree to practice medically acceptable contraception
(i.e., barrier or pharmacologic: male patient must use condoms or his female partner
must take oral contraceptives; the male partner of a female patient must use condoms )
for at least 6 months following the study treatment.

- Conditions/situations such as:

- Recipient not suitable for participation, whatever the reason, as judged by the
Investigator, including medical, clinical, or psychosocial conditions, or patient
potentially at risk of noncompliance to study procedures.

- Donor known or suspected to have active infection before donation (such as blood
cultures positive, seropositive for hepatitis B surface antigen [HBsAg], or
antibody against hepatitis C virus [HCVAb], or human immunodeficiency virus
[HIV]) or hypersensitive recipients (eg, panel reactive antibody [PRA] positive)
before transplantation, judged by the Investigator.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.