A comprehensive monitoring to detect medical non-adherencein kidney transplant recipients

• Conditions: Z94.0; Kidney transplant status

• Registration Number: DRKS00026674
• Lead Sponsor: niversitätsklinik Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-31
• Study Start: 2023-03-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

Informed and written voluntariy consent to participate to this study
- Sufficient physical and mental ability for participation
- Transplanted at the Vienna General Hospital (Medical University of Vienna)
- Continued follow-up care at the department of nephrology and dialysis, devision of internal medicine III, Medical University of Vienna

Exclusion Criteria

- Withdrawal of consent
- Significant language barrier, which impeded the study participation
- Early allograft loss or death before first visit at the out-patient clinic after transplantation
- Follow-up care at a peripheral ambualnce direct after dismission from the ward

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biopsy proven graft rejection.<br>When? - during the whole study period (from day of transplant, up to 4 years post-transplant)<br>How?: Transplant biopsy analyzed by blinded nephropathologist

Secondary Outcome Measures

Name	Time	Method
Death, transplant loss, evaluation of single compartments in the transplant biopsy according to BANFF single scores, de novo donor-specific antibodies (DSA), the estimated glomerular filtration rate (according to current CKD-EPI formula), urinary protein-creatinine ratio, WHOQL-100, urinary chemokines (CXCL 9 and 10); compound endpoint including biopsy proven rejection (primary end-point), de novo DSA and urinary chemokines