Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor kidney transplant patients using a specific type of DNA found in the blood, called donor-derived cell-free DNA (dd-cfDNA). The goal is to see if measuring this DNA can help doctors understand if a patient's body is rejecting the transplanted kidney or if it is functioning well, without needing to perform as many invasive procedures like kidney biopsies. The trial will compare two different follow-up strategies: one group will have regular biopsies at specific times, while the other group will only have biopsies if the dd-cfDNA levels suggest a problem.

To participate in this study, you need to be at least 18 years old and have received a kidney transplant from either a deceased or living donor. You should be able to give your consent and agree to follow the study rules. Importantly, women who could become pregnant must use birth control during the study. If you join, you can expect regular check-ups and to contribute to understanding how to improve care for kidney transplant patients. This trial is not yet recruiting participants, but it aims to help make follow-up care safer and less invasive for people like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All men and women, age ≥18 years old.
• • Subject must be a recipient of a non-combined renal transplant from a deceased or living donor. It can be a re transplantation after a graft loss of function or graft rejection
• • 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.
• Exclusion Criteria:
• • Subjects who are legally detained in an official institution or under legal protection
• • 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).