Molecular characterization of kidney transplant biopsies - identification of pathophysiological mechanisms and development of potential biomarkers

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035745

Enrollment

150

Registered

2025-01-15

Start date

2025-01-20

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z94.0

Interventions

Group 1: The observation group of this retrospective study comprises at least 1,000 transplant biopsies taken and archived at the Heidelberg Kidney Center between 2014 and 2024, with a focus on biopsi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Kidney transplant patients (de-novo or re-transplanted) - Age =18 years - Existing residual material (serum, plasma or biopsy material) without the need for further diagnostics

Exclusion criteria

Exclusion criteria: - Failure to meet the above inclusion criteria - Insufficient documentation available

Design outcomes

Primary

Measure	Time frame
-Evaluation of the analytical validity of the B-HOT panel in terms of reproducibility and calibration at the study center. -Investigation of the benefit of molecular pathology for a more precise diagnosis and prognosis of graft damage with regard to clinical outcomes (e.g. eGFR progression, future rejection, graft loss)	—

Secondary

Measure	Time frame
-Refinement of diagnostic thresholds for borderline changes, acute TCMR and chronically active TCMR (caTCMR): Investigation of the diagnostic sensitivity and specificity of molecular markers in comparison to established histopathologic criteria. -Analysis of the correlation between molecular markers and patient characteristics, transplant-related data (e.g. DSA) and laboratory chemical parameters for risk assessment of graft dysfunction. -Investigation of molecular changes in consecutive biopsies to identify markers that correlate with the progression of graft damage (e.g. from borderline to acute TCMR or from acute to chronic rejection). -Identification of molecular signatures that indicate recurrence of the underlying disease. -Differentiation of interstitial inflammation and tubulitis in BK virus-associated nephropathy from T-cell mediated rejection by molecular signatures. -Identification of potential biomarkers to extend the Banff classification.	—

Measure

Time frame

-Refinement of diagnostic thresholds for borderline changes, acute TCMR and chronically active TCMR (caTCMR): Investigation of the diagnostic sensitivity and specificity of molecular markers in comparison to established histopathologic criteria. -Analysis of the correlation between molecular markers and patient characteristics, transplant-related data (e.g. DSA) and laboratory chemical parameters for risk assessment of graft dysfunction. -Investigation of molecular changes in consecutive biopsies to identify markers that correlate with the progression of graft damage (e.g. from borderline to acute TCMR or from acute to chronic rejection). -Identification of molecular signatures that indicate recurrence of the underlying disease. -Differentiation of interstitial inflammation and tubulitis in BK virus-associated nephropathy from T-cell mediated rejection by molecular signatures. -Identification of potential biomarkers to extend the Banff classification.

—

Countries

Germany

Contacts

Public ContactLouise Benning

Nierenzentrum Heidelberg

louise.benning@med.uni-heidelberg.de+49 6221 9112 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026