Kidney biopsies for suspected acute and chronic rejections in patients with kidney grafts Urological and Genital Diseases
Conditions
Interventions
In this observational, prospective cohort study, the researchers intend to enrol 800 kidney transplantation patients undergoing indication kidney biopsy in five transplantation centers across Germany.
Sponsors
Chiesi (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Patient participates in an interventional trial 2. Previous known concerns regarding compliance 3. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured using patient records annually for 5 years: 1. All-cause mortality 2. Graft survival (defined as the absence of necessity for dialysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records annually for 5 years: 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) 2. Recurrence of graft rejection | — |
Countries
Germany
Outcome results
None listed