This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients (EUTRAIN IMPACT)

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: NCT04774575
Recruitment Status : Active, not recruiting
First Posted : March 1, 2021
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The investigator hypothesize that the combined use of (1) non-invasive biomarkers in peripheral blood predicting anti-donor immunological activation or quiescence (2) interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive and induced risk surveillance by allograft protocol biopsies to assess allograft rejection in clinically stable kidney transplant patients. It is therefore proposed an European, multicenter, prospective randomized comparing two strategies of follow-up: in the first, biopsies are guided by biomarkers, in the second one, a routine biopsy is performed at M3. In both groups, a biopsy is performed at M12 and whenever considered necessary by the clinician.

Condition or disease Intervention/treatment Phase
Renal Transplantation Biological: biomarker-guided strategy Not Applicable

Detailed Description:
The main objective of this study is to demonstrate the ability of use of non-invasive biomarkers to decrease the number of allograft biopsies during the first year after transplantation. 300 new transplanted patients in the 7 clinical transplant sites will be included in the prospective multicentre EU-TRAIN Impact study with centralized storage of samples in CHUN (blood mRNA), ICS (blood cellular assays), Saint -Louis Hospital (blood anti-HLA DSA, and non-HLA antibodies), INSERM (Biopsy mRNA). Recruitment of patients will start on the day of transplantation (d-8 for transplantation from living donors) and data/samples collected over the first year following transplantation. Realization of all the acts for the research are representing the usual medical practice (Standard Of Care: SOC) except six additional blood samples that will be collected and analyzed specifically for the research and additional analysis done specifically for the research on half of one of the two biopsy cores from the recipient. 3 additional blood samples from the living donor will also be collected and analyzed specifically for the research (timepoint of the sampling: anytime from 8 days to the day of transplant.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a 12-month follow-up multicenter, randomized, biomarker strategy design trial, whereby kidney transplant patients will be randomized 1:1 at the time of transplantation in 2 study groups:

  • Group I ("routine group"): Patients will follow a standard clinical follow-up based on kidney allograft function (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) and a surveillance allograft biopsies performed at 3 and 12 months after transplantation (M3 and M12).
  • Group II ("biomarker guided follow-up"): Patients will follow a biomarker-guided strategy based on specific non-invasive biomarkers as defined in EUTRAIN-1 study on the basis of its detection and prediction capacities for rejection at M3 to decide whether a biopsy is performed. At M12 a routine biopsy is performed.

In both groups, a biopsy can be performed up on clinical decision if needed.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Multicentre Trial to Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients" EU-TRAIN IMPACT Trial
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : May 15, 2024
Estimated Study Completion Date : May 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: routine group
Patients will follow a standard clinical follow-up based on kidney allograft function (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) and a surveillance allograft biopsies performed at 3 and 12 months after transplantation (M3 and M12). Visits with biopsies for clinical indication are left to the appreciation of the investigator
Experimental: biomarker guided follow-up

Patients will follow a biomarker-guided strategy based on specific non-invasive biomarkers as defined in EUTRAIN-1 study on the basis of its detection and prediction capacities for rejection at M3 to decide whether a biopsy is performed. At M12 a routine biopsy is performed.

Visits with biopsies for clinical indication are left to the appreciation of the investigator

 Biological: biomarker-guided strategy
Patients will follow a biomarker-guided strategy based on specific non-invasive biomarkers as defined in EUTRAIN-1 study on the basis of its detection and prediction capacities for rejection at M3 to decide whether a biopsy is performed. At M12 a routine biopsy is performed


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The rate of biopsies [ Time Frame: up to 12 months ]
    comparison of the rate of biopsies performed during the first year in the Group of biomarkers guided biopsies vs. routine Group


Secondary Outcome Measures :
  1. Rate of immunosuppressant treatment modifications [ Time Frame: 12month ]
    Rate of immunosuppressant treatment modifications in both groups.

  2. Rate of complications due to performed biopsies [ Time Frame: 12month ]
    Rate of complications due to performed biopsies between both groups

  3. Type of biopsy-proven rejections between both groups [ Time Frame: 12month ]
    Type of biopsy-proven rejections between both groups at 12 months after transplantation

  4. Severity of biopsy-proven rejections between both groups [ Time Frame: 12month ]
    Severity of biopsy-proven rejections between both groups at 12 months after transplantation

  5. Outcome of biopsy-proven rejections between both groups [ Time Frame: 12month ]
    Outcome of biopsy-proven rejections between both groups at 12 months after transplantation

  6. Incidence of death [ Time Frame: 12 months ]
    Incidence of death at 12 months after transplantation

  7. Incidence of allograft loss [ Time Frame: 12 months ]
    Incidence of allograft loss at 12 months after transplantation

  8. Economic impact of implementing biomarkers in European Healthcare systems (cost/benefit) [ Time Frame: up to 12 months ]
    Economic impact of implementing biomarkers in European Healthcare systems (cost/benefit) at 12 months after transplantation

  9. Health-related Quality of life (QoL) of transplant patients after receiving a user-friendly reporting format from the EU-TRAIN report. [ Time Frame: 12 months ]
    Health-related Quality of life (QoL) of transplant patients after receiving a user-friendly reporting format from the EU-TRAIN report.


Other Outcome Measures:
  1. Safety endpoint [ Time Frame: up to 12 months ]
    Comparison of The mean eGFR in both Groups estimated by glomerular filtration rate (CKD-EPI eGFR) at 12 months' post-transplantation and of the number of allograft rejection.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All men and women, age ≥18 years old.
  2. Subject must be a recipient of a single renal transplant from a deceased or living donor.
  3. Subject is willing and able to provide signed written informed consent and willing to comply with study procedures
  4. Women of Childbearing Potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of clinical trial

Exclusion Criteria:

  1. Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive blood PCR result at the moment of transplant).
  2. Subjects with known human immunodeficiency virus (HIV) infection.
  3. Patients with active systemic infection that requires the continued use of antibiotics.
  4. Patients with neoplasia except localized skin cancer receiving appropriate treatment.
  5. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment.
  6. Subjects who are legally detained in an official institution.
  7. Primary non-function or early graft loss due to mechanical/surgical complications.
  8. Death within the first 6 months after transplantation.
  9. Any condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient
  10. History of multi-organ transplant (interference with rejection natural history).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04774575


Locations
Layout table for location information
France
Saint-Louis Hospital, Paris
Paris, Ile De France, France, 75010
Necker Hospital, Paris
Paris, Ile De France, France, 75015
Nantes Hospital
Nantes, France, 44000
Germany
Charité-Universitätsmedizin, Berlin
Berlin, Germany, 10117
Charité-Universitätsmedizin,
Berlin, Germany, 10117
Spain
Vall d'Hebron Hospital
Barcelona, Spain, 08035
Bellvitge University Hospital
Barcelona, Spain, 08907
Switzerland
Geneva University Hospitals
Geneva, Geneve, Switzerland, 1205
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Study Director: Alexandre Loupy, Pr APHP
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04774575    
Other Study ID Numbers: APHP200984
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
renal transplantation
non-invasive biomarkers
risk evaluation
randomized trial