AzTrials
AzTrials

Kidney Transplant RejectioncfDNA-DSANCT04897438

Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection

A study testing Kidney allograft biopsy depending on donor-derived cell-free DNA levels in people with Kidney Transplant Rejection and Antibody-mediated Rejection, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Patients after kidney transplantation who develop donor-specific antibodies (DSA) are at high risk for antibody-mediated rejection (ABMR). Donor-derived cell-free DNA (dd-cfDNA) levels have been shown to be increased in patients with active or chronic active ABMR. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Kidney allograft biopsy depending on donor-derived cell-free DNA levels
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGermany
Study dates
1 Jun 2021to 9 Sep 2024
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients 18 years or older
  • patients provided written informed consent
  • patients after kidney transplantation
  • functioning kidney allograft, at least after 180 days after last transplantation
  • estimated glomerular filtration rate above 20 ml/min/1.73m^2
  • detection of DSA

Who cannot join

  • patients younger than 18 years
  • patients unable or did not provide written informed consent
  • pregnant or breastfeeding persons
  • patients with increased bleeding risk
  • patients with multi-organ transplantation
  • patients who underwent kidney allograft biopsy after first detection of DSA
  • biopsy-proven antibody-mediated rejection
  • participation in another interventional clinical trial

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité-Universitätsmedizin

    Berlin, 10117

Other trials in Germany

About this study

Official title: Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection in Kidney Transplant Recipient with Donor-specific Antibodies

Patients after kidney transplantation who develop donor-specific antibodies (DSA) are at high risk for antibody-mediated rejection (ABMR). Donor-derived cell-free DNA (dd-cfDNA) levels have been shown to be increased in patients with active or chronic active ABMR. This study aims to evaluate if repeated analysis of dd-cfDNA in patients with DSA and kidney allograft biopsy which is triggered by increased levels of dd-cfDNA can lead to early diagnosis of active or chronic active ABMR among these patients.

Being tested
Kidney allograft biopsy depending on donor-derived cell-free DNA levels

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kidney allograft biopsy depending on donor-derived cell-free DNA levelsProcedure or surgery

    Kidney allograft biopsy is performed, when absolute levels of donor-derived cell-free DNA are above 50 copies/ml

Study groups in NCT04897438
Study groupRoleWhat they receive
InterventionExperimentalAdditionally to standard of care, measurements for donor-derived cell-free DNA (dd-cfDNA) are performed at months 0, 1, 3, 6, 9, and 12. If absolute levels of dd-cfDNA are > 50 copies/ml, the patients receive a kidney allograft biopsy. Additionally, kidney allograft biopsies are performed according to standard of care as determined by the treating physicians.
Receives: Procedure: Kidney allograft biopsy depending on donor-derived cell-free DNA levels
ControlNo interventionAdditionally to standard of care, measurements for donor-derived cell-free DNA (dd-cfDNA) are performed at months 0, 1, 3, 6, 9, and 12. These measurements are not used to guide kidney allograft biopsies. Those are performed according to standard of care as determined by the treating physicians.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from study inclusion to diagnosis of antibody-mediated rejection

    Time from study inclusion date to biopsy-proven diagnosis of active or chronic active antibody-mediated rejection

    Measured: 12 months after inclusion

Secondary outcomes (22)

  1. Sensitivity of absolute dd-cfDNA for detection of ABMR

    Sensitivity of dd-cfDNA > 50 copies/ml to predict the occurence of active or chronic active ABMR in patients with DSA.

    Measured: 12 Months

  2. Specificity of absolute dd-cfDNA for detection of ABMR

    Specificity of dd-cfDNA > 50 copies/ml to predict the occurence of active or chronic active ABMR in patients with DSA.

    Measured: 12 Months

  3. Receiver operating characteristics (ROC) analysis of absolute dd-cfDNA for detection of ABMR

    ROC analysis for dd-cfDNA to predict the occurence of active or chronic active ABMR in patients with DSA.

    Measured: 12 Months

  4. Sensitivity of intraindividual dd-cfDNA changes for detection of ABMR

    Sensitivity of dd-cfDNA increase of > 25% to predict the occurence of active or chronic active ABMR in patients with DSA.

    Measured: 12 Months

  5. Sensitivity of combined dd-cfDNA criterion for detection of ABMR

    Sensitivity of the combination of "dd-cfDNA increase of > 25%" OR "absolute dd-cfDNA > 50 copies/ml" to predict the occurence of active or chronic active ABMR in patients with DSA.

    Measured: 12 Months

  6. Clinical Outcome - estimated glomerular filtration rate (eGFR) 12 Months

    Difference between eGFR decline after 12 months between control group and intervention group.

    Measured: 12 Months

  7. Clinical Outcome - eGFR 24 Months

    Difference between eGFR decline after 24 months between control group and intervention group.

    Measured: 24 Months

  8. Clinical Outcome - albuminuria 12 Months

    Difference between albuminuria after 12 months between control group and intervention group.

    Measured: 12 Months

  9. Clinical Outcome - albuminuria 24 Months

    Difference between albuminuria after 24 months between control group and intervention group.

    Measured: 24 Months

  10. Clinical Outcome - Death-censored Graft Failure 12 Months

    Difference in Death-censored Graft Failure after 12 months between control group and intervention group.

    Measured: 12 Months

  11. Clinical Outcome - Death-censored Graft Failure 24 Months

    Difference in Death-censored Graft Failure after 24 months between control group and intervention group.

    Measured: 24 Months

  12. Clinical Outcome - Mortality 12 Months

    Difference in Mortality after 12 months between control group and intervention group.

    Measured: 12 Months

  13. Clinical Outcome - Mortality 24 Months

    Difference in Mortality after 24 months between control group and intervention group.

    Measured: 24 Months

  14. Clinical Outcome - Severe Infection 12 Months

    Difference in occurence of severe infections (hospitalization, organ failure, death) during 12 months between control group and intervention group.

    Measured: 12 Months

  15. Clinical Outcome - Severe Infection 24 Months

    Difference in occurence of severe infections (hospitalization, organ failure, death) during 24 months between control group and intervention group.

    Measured: 24 Months

  16. Adverse Events of Kidney Transplant Biopsy

    Occurence of Complications from Kidney Transplant Biopsies, including Duration and potential therapy to treat the adverse event.

    Measured: 12 Months

  17. Rate of ABMR

    Number of biopsy proven active or chronic active ABMR in the cohort.

    Measured: 12 Months

  18. DSA Levels 0 Months

    Mean fluorescence intensity of immunodominant DSA

    Measured: at inclusion

  19. DSA Levels 12 Months

    Mean fluorescence intensity of immunodominant DSA at 12 months

    Measured: 12 months

  20. DSA Levels 24 Months

    Mean fluorescence intensity of immunodominant DSA at 24 months

    Measured: 24 months

  21. Immunosuppressive Regimen

    Report of immunosuppressive medication at the following time points: 0,1,3,6,9,12,24 months, changes of medication, additional therapies such as plasmapheresis, or experimental therapies.

    Measured: 24 months

  22. Time from first DSA occurrence to diagnosis of antibody-mediated rejection

    Time from first DSA occurrence to biopsy-proven diagnosis of active or chronic active antibody-mediated rejection

    Measured: 12 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study start1 Jun 2021
  3. Primary completion18 Jul 2023
  4. Study completion9 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04897438
Sponsor's protocol ID
CHA-NTX-001
Acronym
cfDNA-DSA
Status last verified
Jan 2025
First submitted
18 May 2021
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Akifova A, Budde K, Amann K, Buettner-Herold M, Choi M, Oellerich M, Beck J, Bornemann-Kolatzki K, Schutz E, Bachmann F, Halleck F, von Hoerschelmann E, Koch N, Schrezenmeier E, Seelow E, Waiser J, Zukunft B, Eckardt KU, Halbritter J, Kettritz R, Del Moral CL, Lachmann N, Stauch D, Niemann M, Schmidt D, Halloran PF, Osmanodja B. Donor-derived cell-free DNA monitoring for early diagnosis of antibody-mediated rejection after kidney transplantation: a randomized trial. Nephrol Dial Transplant. 2025 Jun 30;40(7):1384-1395. doi: 10.1093/ndt/gfae282.

    PubMed 39673311

  • Oellerich M, Budde K, Osmanodja B, Bornemann-Kolatzki K, Beck J, Schutz E, Walson PD. Donor-Derived Cell-free DNA for Personalized Immunosuppression in Renal Transplantation. Ther Drug Monit. 2023 Feb 1;45(1):20-25. doi: 10.1097/FTD.0000000000001023.

    PubMed 36127770

Questions about this trial

What is this clinical trial studying?

A study testing Kidney allograft biopsy depending on donor-derived cell-free DNA levels in people with Kidney Transplant Rejection and Antibody-mediated Rejection, run by Charite University, Berlin, Germany at 1 site in Germany.

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 6 inclusion and 8 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 22 Jan 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 Germany. 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?

Time from study inclusion to diagnosis of antibody-mediated rejection (time frame: 12 months after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04897438, which also lists 2 linked publications.

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 22 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in