TRABIO: registry for documenting treatment success after kidney transplant rejections
Not Applicable
- Conditions
- Kidney biopsies for suspected acute and chronic rejections in patients with kidney graftsUrological and Genital Diseases
- Registration Number
- ISRCTN78772632
- Lead Sponsor
- Chiesi (Germany)
- Brief Summary
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35450886/ (added 25/04/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
1. Patients that have previously received a living- or deceased-donor kidney transplantation
2. Suspicion of graft rejection with a medical indication for a kidney biopsy
3. Male and female patients 18 years or older
4. Written, informed consent
Exclusion Criteria
1. Patient participates in an interventional trial
2. Previous known concerns regarding compliance
3. Pregnancy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Measured using patient records annually for 5 years:<br> 1. All-cause mortality<br> 2. Graft survival (defined as the absence of necessity for dialysis)<br>
- Secondary Outcome Measures
Name Time Method <br> Measured using patient records annually for 5 years:<br> 1. Decline in kidney function (=30% decline of estimated glomerular filtration rate [eGFR] calculated from blood creatinine test, age, body size and gender; or new-onset large proteinuria with >300 mg/dl on urine dipstick)<br> 2. Recurrence of graft rejection<br>