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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

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date February 21, 2020
Actual Study Start Date  ICMJE August 16, 2017
Actual Primary Completion Date November 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
Percentage of patients with biopsy-proven acute rejection events [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
  • Percentage of delayed graft function events [ Time Frame: 6 months ]
  • Duration of delayed graft function events [ Time Frame: 6 months ]
  • Percentage of survived grafts [ Time Frame: 6 months ]
  • Percentage of survived patients [ Time Frame: 6 months ]
  • Assessment of acute rejection risk factors [ Time Frame: 6 months ]
  • Assessment of delayed graft function risk factors [ Time Frame: 6 months ]
  • Percentage of acute rejection events in different risk stratifications [ Time Frame: 6 months ]
  • Percentage of delayed graft function events in different risk stratifications [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
Official Title  ICMJE A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE End-stage Renal Disease
Intervention  ICMJE
  • 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

Study Arms  ICMJE 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.

Interventions:
  • Biological: Rabbit Anti-thymocyte Immunoglobulin
  • Drug: Tacrolimus
  • Drug: Methylprednisolone
  • Drug: Mycophenolate mofetil
  • Drug: Mycophenolate Na
  • Drug: prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2019)
115
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2017)
200
Actual Study Completion Date  ICMJE November 12, 2019
Actual Primary Completion Date November 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099122
Other Study ID Numbers  ICMJE THYMOL07282
U1111-1178-5402 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP