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.