Status:
COMPLETED
Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
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 trans...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04774575
Start Date
December 15 2021
End Date
May 29 2024
Last Update
June 3 2024
Active Locations (8)
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1
Nantes Hospital
Nantes, France, 44000
2
Saint-Louis Hospital, Paris
Paris, Île-de-France Region, France, 75010
3
Necker Hospital, Paris
Paris, Île-de-France Region, France, 75015
4
Charité-Universitätsmedizin, Berlin
Berlin, Germany, 10117