Donor-derived Cell-free DNA in Kidney Transplant Recipients

NCT06476717 | Completed

• 1 other identifier: 15689/21
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

Donor-derived cell-free DNA (dd-cfDNA) is a promising non-invasive biomarker of kidney allograft rejection. In this prospective, single center, observational monitoring study, we aim to evaluate a role of dd-cfDNA in predicting kidney allograft injuries, i.e. rejection and non-rejection injuries within 12 months, and to monitor the effect of anti rejection treatment.

Conditions

Kidney Transplantation; Acute Rejection of Renal Transplant

Keywords

Kidney Transplantation; Acute Rejection of Renal Transplant; dd-cfDNA; non-invasive test

Outcome Measures

Primary Outcomes (2)

• dd-cfDNA

  dd-cfDNA monitoring active rejection and other allograft injuries

  12 months

• dd-cfDNA

  Monitoring of effects of antirejection treatment

  4 weeks

Study Arms (2)

Prospective monitoring within 1 year follow-up

Patients after kidney transplantation from deceased donors (n=100) were prospectively enrolled and dd-cf DNA levels were measured at defined timepoints (0, D14, 1,2,3,4,6,9 and 12 months) within 12 months.

Procedure: Biopsy; Diagnostic Test: Blood Biomarkers - cfDNA

The effect of treatment cohort

Patients were enrolled at the time of biopsy with histologic and /or molecular signs of rejection. Donor-derived cell-free DNA (dd-cf DNA) were measured at the time of biopsy before centre standard of care treatment and then at weeks 1, 2 and 3 after biopsy.

Procedure: Biopsy; Diagnostic Test: Blood Biomarkers - cfDNA; Drug: Antirejection therapy

Interventions

Biopsy PROCEDURE

Kidney allograft biopsy

Prospective monitoring within 1 year follow-up; The effect of treatment cohort

Blood Biomarkers - cfDNA DIAGNOSTIC_TEST

dd-cfDNA

Also known as: dd-cfDNA

Prospective monitoring within 1 year follow-up; The effect of treatment cohort

Antirejection therapy DRUG

Patients will receive standard antirejection therapy according to center protocol.

The effect of treatment cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients. Patients will receive standard immunosuppression based on tacrolimus, mycophenolate mofetil and steroids along with induction (basiliximab in low risk and rATG in high-risk) according to center protocol. All procedures in transplant recipients will be routine ones, included for cause biopsies and 3M protocol biopsy or antirejection therapy (standard of care in the center). Antirejection therapies are defined by center protocol and clinical team decision.

You may qualify if:

• Recipient age ≥ 18 years and \<85 years
• Written Informed Consent cohort 1
• deceased donor kidney transplant recipient cohort 2
• patients with kidney allograft biopsy at center showing any type of rejection which is going to be treated
• patient wishing to repeatedly travel to center

You may not qualify if:

• cohort 1
• living donor
• multiple transplant
• dual transplant
• haematopoetic stem cell transplant in a history

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead
• Natera, Inc.: collaborator

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Czechia, 140 21, Czechia

Location

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood samples of recipient

MeSH Terms

Interventions

Biopsy; Immunosuppression Therapy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques

Study Officials

• Ondrej Viklicky, M.D., Ph.D.

  Dept. of Nephrology, IKEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Nephrology and Transplant Center

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: October 21, 2021
• Primary Completion: May 12, 2024
• Study Completion: May 20, 2024
• Last Updated: May 1, 2025

Record last verified: 2024-06

Locations

CZ (1)