Clinical trial NCT03099122: A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
Official title: A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End-stage Renal Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of patients with biopsy-proven acute rejection events
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of delayed graft function events
timeFrame: 6 months
measure: Duration of delayed graft function events
timeFrame: 6 months
measure: Percentage of survived grafts
timeFrame: 6 months
measure: Percentage of survived patients
timeFrame: 6 months
measure: Assessment of acute rejection risk factors
timeFrame: 6 months
measure: Assessment of delayed graft function risk factors
timeFrame: 6 months
measure: Percentage of acute rejection events in different risk stratifications
timeFrame: 6 months
measure: Percentage of delayed graft function events in different risk stratifications
timeFrame: 6 months
Other outcomes:
Locations:
city: China
country: China
facility: CHINA
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: