Kidney TransplantationDEFILENCT06476717
Donor-derived Cell-free DNA in Kidney Transplant Recipients
An observational study of Kidney Transplantation and Acute Rejection of Renal Transplant, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kidney Transplantation, Acute Rejection of Renal Transplant
- What is being tested?
- Biopsy, Blood Biomarkers - cfDNA and Antirejection therapy
- Type of treatment
- Surgery or procedure
- How many people
- 143 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Oct 2021to 20 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- cohort 1
- living donor
- multiple transplant
- dual transplant
- haematopoetic stem cell transplant in a history
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Institute for Clinical and Experimental Medicine
Prague, Czechia, 140 21
About this study
Official title: Donor-derived Cell-free DNA (Dd-cfDNA) Monitoring to Detect Kidney Allograft Injury and Monitor the Effect Anti-rejection Treatment
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.
Read the detailed description
Kidney transplantation represents the best therapeutic option in patients with end-stage kidney disease. Among main causes of graft loss belongs kidney allograft rejection which is diagnosed based on histology/molecular assessment of biopsy sample. This is invasive procedure, but provides more precise result regarding type of rejection. Contrary, donor-derived cell-free DNA (dd-cfDNA) is a novel non-invasive biomarker of allograft rejection with excellent negative predictive power. Moreover it may be useful for predicting allograft injuries and resolution of injuries after treatment.
In the prospective cohort, 100 renal allograft patients will be enrolled and dd-cfDNA levels determined from blood collected at predefined time points (preTX, POD14, M1, 2, 3, 4, 6, 9, 12).
In the second cohort, 40 patients will be enrolled at the time of biopsy with histological and/or molecular diagnosis of rejection and dd-cfDNA levels measured just before initiation of treatment and then at week 1, 2 and 3 after biopsy.
Peripheral blood will be collected in 2x 10 ml cfDNA (Streck) collection tubes for each study visit and dd-cfDNA will be quantified by the Prospera™ test (Natera Inc., Austin, Texas).
All patients will receive standard of care treatment according to centre protocol and no patients or providers will receive the results of dd-cfDNA testing during the study. Study protocol and patient informed consent were approved by Ethical committee.
- Being tested
- Biopsy, Blood Biomarkers - cfDNA, Antirejection therapy
- Keywords
- Kidney Transplantation, Acute Rejection of Renal Transplant, dd-cfDNA, non-invasive test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Kidney allograft biopsy
Blood Biomarkers - cfDNADiagnostic test
Also called dd-cfDNA
dd-cfDNA
Antirejection therapyDrug
Patients will receive standard antirejection therapy according to center protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Biopsy; Diagnostic Test: Blood Biomarkers - cfDNA; Drug: Antirejection therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
dd-cfDNA
dd-cfDNA monitoring active rejection and other allograft injuries
Measured: 12 months
dd-cfDNA
Monitoring of effects of antirejection treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start21 Oct 2021
- Primary completion12 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Collaborators
- Natera, Inc.
- Responsible party
- Principal investigator, Prof. Ondřej Viklický, M.D., Ph.D., Institute for Clinical and Experimental Medicine
- Investigators
- Ondrej Viklicky, M.D., Ph.D., Principal investigator, Dept. of Nephrology, IKEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476717
- Sponsor's protocol ID
- 15689/21
- Acronym
- DEFILE
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor-derived Cell-free DNA (Dd-cfDNA) Monitoring to Detect Kidney Allograft Injury and Monitor the Effect Anti-rejection Treatment
- ClinicalTrials.gov ID
- NCT06476717
- Acronym / sponsor ID
- DEFILE / 15689/21
- Keywords
- Kidney Transplantation, Acute Rejection of Renal Transplant, dd-cfDNA, non-invasive test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Collaborators
- Natera, Inc.
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 12 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Kidney transplantation represents the best therapeutic option in patients with end-stage kidney disease. Among main causes of graft loss belongs kidney allograft rejection which is diagnosed based on histology/molecular assessment of biopsy sample. This is invasive procedure, but provides more precise result regarding type of rejection. Contrary, donor-derived cell-free DNA (dd-cfDNA) is a novel non-invasive biomarker of allograft rejection with excellent negative predictive power. Moreover it may be useful for predicting allograft injuries and resolution of injuries after treatment.
In the prospective cohort, 100 renal allograft patients will be enrolled and dd-cfDNA levels determined from blood collected at predefined time points (preTX, POD14, M1, 2, 3, 4, 6, 9, 12).
In the second cohort, 40 patients will be enrolled at the time of biopsy with histological and/or molecular diagnosis of rejection and dd-cfDNA levels measured just before initiation of treatment and then at week 1, 2 and 3 after biopsy.
Peripheral blood will be collected in 2x 10 ml cfDNA (Streck) collection tubes for each study visit and dd-cfDNA will be quantified by the Prospera™ test (Natera Inc., Austin, Texas).
All patients will receive standard of care treatment according to centre protocol and no patients or providers will receive the results of dd-cfDNA testing during the study. Study protocol and patient informed consent were approved by Ethical committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective monitoring within 1 year follow-up | – | Procedure: Biopsy, Diagnostic Test: Blood Biomarkers - cfDNAPatients 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. |
| The effect of treatment cohort | – | Procedure: Biopsy, Diagnostic Test: Blood Biomarkers - cfDNA, Drug: Antirejection therapyPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- cohort 1
- living donor
- multiple transplant
- dual transplant
- haematopoetic stem cell transplant in a history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyKidney allograft biopsy | Procedure or surgery | Prospective monitoring within 1 year follow-up, The effect of treatment cohort |
| Blood Biomarkers - cfDNAAlso: dd-cfDNAdd-cfDNA | Diagnostic test | Prospective monitoring within 1 year follow-up, The effect of treatment cohort |
| Antirejection therapyPatients will receive standard antirejection therapy according to center protocol. | Drug | The effect of treatment cohort |
Primary outcome
dd-cfDNA
Time frame: 12 months
dd-cfDNA monitoring active rejection and other allograft injuries
dd-cfDNA
Time frame: 4 weeks
Monitoring of effects of antirejection treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ondrej Viklicky, M.D., Ph.D. principal investigator
Dept. of Nephrology, IKEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Acute Rejection of Renal Transplant, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dd-cfDNA (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.