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

NCT03099122 | Completed Phase 4

• 2 other identifiers: THYMOL07282U1111-1178-5402
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with biopsy-proven acute rejection events

  6 months

Secondary Outcomes (8)

• Percentage of delayed graft function events

  6 months

• Duration of delayed graft function events

  6 months

• Percentage of survived grafts

  6 months

• Percentage of survived patients

  6 months

• Assessment of acute rejection risk factors

  6 months

Study Arms (1)

Thymoglobuline

EXPERIMENTAL

A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice. Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies.

Biological: Rabbit Anti-thymocyte Immunoglobulin; Drug: Tacrolimus; Drug: Methylprednisolone; Drug: Mycophenolate mofetil; Drug: Mycophenolate Na; Drug: prednisone

Interventions

Rabbit Anti-thymocyte Immunoglobulin BIOLOGICAL

Pharmaceutical form: creamy-white powder Route of administration: intravenous

Also known as: Thymoglobuline

Thymoglobuline

Tacrolimus DRUG

Pharmaceutical form: tablet Route of administration: oral

Thymoglobuline

Methylprednisolone DRUG

Pharmaceutical form: powder Route of administration: intravenous

Thymoglobuline

Mycophenolate mofetil DRUG

Pharmaceutical form: capsule Route of administration: oral

Thymoglobuline

Mycophenolate Na DRUG

Pharmaceutical form: capsule Route of administration: oral

Thymoglobuline

prednisone DRUG

Pharmaceutical form: tablet Route of administration: oral

Thymoglobuline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

CHINA

China, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Antilymphocyte Serum; Tacrolimus; Methylprednisolone; Mycophenolic Acid; Prednisone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Macrolides; Lactones; Organic Chemicals; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Pregnadienediols

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: August 16, 2017
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)