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A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant (START-DCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099122
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Biological: Rabbit Anti-thymocyte Immunoglobulin Drug: Tacrolimus Drug: Methylprednisolone Drug: Mycophenolate mofetil Drug: Mycophenolate Na Drug: prednisone Phase 4

Detailed Description:
The total study duration per patient is 6.5 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : November 12, 2019
Actual Study Completion Date : November 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thymoglobuline

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

Pharmaceutical form: creamy-white powder

Route of administration: intravenous

Other Name: Thymoglobuline

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





Primary Outcome Measures :
  1. Percentage of patients with biopsy-proven acute rejection events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Percentage of delayed graft function events [ Time Frame: 6 months ]
  2. Duration of delayed graft function events [ Time Frame: 6 months ]
  3. Percentage of survived grafts [ Time Frame: 6 months ]
  4. Percentage of survived patients [ Time Frame: 6 months ]
  5. Assessment of acute rejection risk factors [ Time Frame: 6 months ]
  6. Assessment of delayed graft function risk factors [ Time Frame: 6 months ]
  7. Percentage of acute rejection events in different risk stratifications [ Time Frame: 6 months ]
  8. Percentage of delayed graft function events in different risk stratifications [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099122


Locations
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China
CHINA
China, China
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03099122    
Other Study ID Numbers: THYMOL07282
U1111-1178-5402 ( Other Identifier: UTN )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Death
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Pathologic Processes
Mycophenolic Acid
Prednisone
Methylprednisolone
Tacrolimus
Thymoglobulin
Antilymphocyte Serum
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular