CD8+ CD38+ T cells in urine as a biomarker for transplant rejection

CD8+ CD38+ T cells in urine as a biomarker for transplant rejection - UTX-CD38

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035182

Enrollment

103

Registered

2024-10-01

Start date

2024-10-10

Completion date

Unknown

Last updated

2025-10-06

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: Validation of CD8+ CD38+ T cells in urine as a biomarker for transplant rejection. Included in the study are kidney transplant patients with an indication for graft biopsy due to suspected re

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Kidney transplant, indication biopsy, suspected kidney transplant rejection

Exclusion criteria

Exclusion criteria: Urinary tract infection

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the validation of the diagnostic accuracy of CD8+ CD38+ T cells in urine, analyzed by flow cytometry, for predicting transplant rejection compared to the biopsy-based diagnosis. Specifically, the primary endpoint is the sensitivity and specificity of the cell count in urine to accurately predict the biopsy diagnosis of rejection.	—

Secondary

Measure	Time frame
T cell-mediated rejection, antibody-mediated rejection, other diagnoses on biopsy than rejection	—

Countries

Germany

Contacts

Public ContactNina Görlich

Charité Universitätsmedizin Berlin

nina.goerlich@charite.de+4915174516961

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026