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Evaluation of Transplant-reactive T cells for the Prediction or Diagnosis of Transplant Rejection in Kidney Transplant Recipients (TreaT-Assay)

Evaluation of Transplant-reactive T cells for the Prediction or Diagnosis of Transplant Rejection in Kidney Transplant Recipients (TreaT-Assay) - TreaT-Assay

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028707
Enrollment
185
Registered
2022-04-27
Start date
2022-05-18
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

T86.10 T86.11 T86.12 T86.19

Interventions

Group 1: Kidney transplant patients are included at the time of deterioration of graft function with indication for renal biopsy. Immunological tests will be performed in parallel. Arm 1 includes pati

Sponsors

Charité Campus Virchow-Klinikum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: - Condition after kidney transplant or non-kidney transplant control - Deterioration of transplant function and indication for renal transplant biopsy - Signed informed consent form - Age >18 years - Existing health insurance

Exclusion criteria

Exclusion criteria: - Age under 18 years - Lack of capacity to give consent - Lack of written informed consent - viral infections such as hepatitis B, hepatitis C or/and HIV

Design outcomes

Primary

MeasureTime frame
Diagnosis of acute T-cell mediated rejection according to Banff classification in renal biopsy during the observation period (6 months)

Secondary

MeasureTime frame
- Other pathologic findings on renal biopsy - Evolution of glomerular filtration rate, creatinine level, protein in urine, and BK viral load in blood and urine during the study period - Graft failure/loss - Requirement for dialysis - Therapeutic interventions, need for immunosuppressive medications during the observation period (6 months)

Countries

Germany

Contacts

Public ContactConstantin Thieme

Charité - Universitätsmedizin BerlinBIH Center for Regenerative Therapies (BCRT)Berlin Center for Advanced Therapies (BeCAT)

constantin.thieme@charite.de+49 (0) 30 450 524324

Outcome results

None listed

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