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

Recruiting

• Conditions: T86.10; T86.11; T86.12; T86.19

• Registration Number: DRKS00028707
• Lead Sponsor: Charité Campus Virchow-Klinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 185

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
- 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)