Status:
COMPLETED
Development of Antibodies Against Transplant Kidney After Infection
Lead Sponsor:
University Hospital Ostrava
Conditions:
Acute Infection
Kidney Failure
Eligibility:
All Genders
18+ years
Brief Summary
Kidney transplantation is the best method of renal replacement in patients with irreversible renal failure. One of the biggest problems today is premature loss of function of the transplanted kidney. ...
Detailed Description
Kidney transplantation significantly improves the prognosis and quality of life of patients with irreversible renal failure (end-stage kidney disease), requiring hemodialysis or peritoneal dialysis. T...
Eligibility Criteria
Inclusion
- Age 18 years and over.
- A kidney transplant patient - from a living donor or from a cadaveric donor (donor after circulatory or brain death). The patient will be included after 1st transplant and possible retransplantation.
- The patient is hospitalized or newly admitted to the FN Ostrava internal clinic for acute infection + requires the reduction of immunosuppressive therapy (dose reduction or discontinuation of any of the maintenance immunosuppressive preparations - tacrolimus, cyclosporin A, sirolimus, everolimus, azathioprine, mycophenolate).
- Acute infection (to be admitted to an internal clinic - determine the time of admission or the time of the first symptom of infection in the already hospitalized) occurred at least more than 48 hours after transplantation (from reperfusion time) and a maximum of 10 years after transplantation.
- The patient did not receive intravenous immunoglobulins within the last 24 hours prior to first sampling.
- This is not a pregnant woman.
Exclusion
- Patient's death before the 2nd blood sampling.
- The patient condition was conclusively determined as something other than acute infection (acute rejection episode, acute pancreatitis, malignant tumor, ...). Unfamiliarity with localization of the infection or its origin, assuming an infectious etiology, is NOT an exclusion criterion.
- The patient was graftectomized - removal of the transplanted kidney, between the 1st and 2nd antibody determination.
- Detection of pregnancy when the term of conception is calculated before the 2nd antibody count.
- One or more transfusions of the erythrocytes or plasma between the 1st and 2nd measurements were administered to the patient.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06040684
Start Date
August 1 2018
End Date
December 31 2021
Last Update
September 15 2023
Active Locations (1)
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1
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 708 52