Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients

NCT04774575 | Completed

• 1 other identifier: APHP200984
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 8

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.

Conditions

Renal Transplantation

Keywords

renal transplantation; non-invasive biomarkers; risk evaluation; randomized trial

Outcome Measures

Primary Outcomes (1)

• The rate of biopsies

  comparison of the rate of biopsies performed during the first year in the Group of biomarkers guided biopsies vs. routine Group

  up to 12 months

Secondary Outcomes (9)

• Rate of immunosuppressant treatment modifications

  12month

• Rate of complications due to performed biopsies

  12month

• Type of biopsy-proven rejections between both groups

  12month

• Severity of biopsy-proven rejections between both groups

  12month

• Outcome of biopsy-proven rejections between both groups

  12month

Other Outcomes (1)

• Safety endpoint

  up to 12 months

Study Arms (2)

routine group

NO INTERVENTION

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

biomarker guided follow-up

EXPERIMENTAL

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

Interventions

biomarker-guided strategy BIOLOGICAL

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

biomarker guided follow-up

Eligibility Criteria

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

You may qualify if:

• All men and women, age ≥18 years old.
• Subject must be a recipient of a single renal transplant from a deceased or living donor.
• Subject is willing and able to provide signed written informed consent and willing to comply with study procedures
• 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

You may not qualify if:

• Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive blood PCR result at the moment of transplant).
• Subjects with known human immunodeficiency virus (HIV) infection.
• Patients with active systemic infection that requires the continued use of antibiotics.
• Patients with neoplasia except localized skin cancer receiving appropriate treatment.
• 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.
• Subjects who are legally detained in an official institution.
• Primary non-function or early graft loss due to mechanical/surgical complications.
• Death within the first 6 months after transplantation.
• 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
• History of multi-organ transplant (interference with rejection natural history).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (8)

Nantes Hospital

Nantes, 44000, France

Location

Saint-Louis Hospital, Paris

Paris, Île-de-France Region, 75010, France

Location

Necker Hospital, Paris

Paris, Île-de-France Region, 75015, France

Location

Charité-Universitätsmedizin, Berlin

Berlin, 10117, Germany

Location

Charité-Universitätsmedizin,

Berlin, 10117, Germany

Location

Vall d'Hebron Hospital

Barcelona, 08035, Spain

Location

Bellvitge University Hospital

Barcelona, 08907, Spain

Location

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

Location

Study Officials

• Alexandre Loupy, Pr

  APHP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: December 15, 2021
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

ES (2); FR (3); DE (2); CH (1)