Development of Antibodies Against Transplant Kidney After Infection

NCT06040684 | Completed

• 2 other identifiers: INT-01-HLATX-Kidney15/RVO-FNOs/2018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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. This occurs most often on the basis of chronic humoral rejection. This is the immune response to the kidney, in which the specific antibodies play a crucial role (both against the HLA and the non-HLA system). The aim of this study is to analyze one of the situations where the production of antibodies can begin to occur. This is a serious acute infection (bacterial, viral, or fungal), where it is necessary to significantly reduce doses of immunosuppressives. At the time of reduced immunosuppression, the immune system can recognize the transplanted kidney as foreign to the human body and begin to fight against it. In this study, the investigators will monitor antibodies against the transplanted kidney in patients with severe acute infection. A serious infection in this study is one that requires acute hospitalization and reduced doses of immunosuppressive drugs. The researchers will measure the antibodies in the blood upon admission and then in 5 weeks.

Conditions

Acute Infection; Kidney Failure

Keywords

kidney transplant; HLA antibodies; acute infection

Outcome Measures

Primary Outcomes (1)

• Production of HLA and nonHLA antibodies - Luminex

  Screening for HLA and nonHLA antibodies by Luminex. The test result will be positive (MFI - mean fluorescence intensity above 300) or negative.

  42 months

Secondary Outcomes (13)

• Analysis of antibody formation according to age

  42 months

• Analysis of antibody formation according to time from transplantation

  42 months

• Creatinine value

  42 months

• Input Inflammatory Parameters - CRP (C-reactive protein)

  42 months

• Input Inflammatory Parameters - IL-6 (Interleukin-6)

  42 months

Study Arms (1)

Level of antibodies in kidney transplant recipients

Patients with kidney transplant with a severe acute infection will be enrolled in the study. Levels of antibodies in these patients will be analyzed.

Diagnostic Test: Level of antibodies

Interventions

Level of antibodies DIAGNOSTIC_TEST

The level of antibodies against transplanted kidney in patients with a severe acute infection will be measured upon admission and then in 5 weeks.

Level of antibodies in kidney transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Kidney transplant recipients with acute infection (viral, bacterial or fungal) requiring acute inpatient care

You may qualify if:

• 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.

You may not qualify if:

• Patient's death before the 2nd blood sampling.
• 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.

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Antibodies in blood samples (excessive material remaining after performing all necessary standard diagnostic tests) will be analyzed upon admission and then in 5 weeks.

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Zdeněk Lys, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: September 15, 2023
• Study Start: August 1, 2018
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)