Status:
COMPLETED
Urinary Biomarkers in Paediatric Kidney Transplantation (pKTx)
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Natural and Medical Sciences Institute (NMI)
Cooperative European Paediatric Renal Transplant Initiative (CERTAIN)
Conditions:
Renal Transplantation
Chronic Kidney Insufficiency
Eligibility:
All Genders
Up to 17 years
Brief Summary
This study aims to test and validate the panel of study urinary biomarker to assess whether (1) reference values differ between paediatric renal transplant patients, patients with chronic kidney disea...
Detailed Description
Despite advances in kidney transplantation, acute rejection (AR) is one of the primary risk factors for allograft kidney injury and function deterioration, and may have a significant impact on long-te...
Eligibility Criteria
Inclusion
- i) Group 1 (patients \< 18 years of age)- obtaining reference values without any of the pre-defined events
- renal transplant patients with stable renal function parameters (mean SCr (or cystatin C) or mean eGFR based on creatinine and / or cystatin C defined as changes ≤ ±15 % for at least three consecutive ambulatory controls).
- patients with CKD IV-V (and maintained urine output, without renal replacement therapy and without pre-defined events).
- healthy controls.
- Study patients from group 1 may be assigned to the group 2 in the following conditions:
- ii) Group 2 (patients \< 18 years of age)- obtaining biomarker-specific characteristic in the presence of any of the pre-defined events
- renal transplant recipients with living or deceased kidney transplantation.
- patients with CKD IV-V (and maintained urine output without renal replacement therapy).
- healthy controls.
Exclusion
- i) Healthy controls
- any comorbidity / medication which may have an impact on urinary biomarker profile (e.g. primary kidney or liver disease, metabolic disease, vasculitis or other immunological disease other than the pre-defined events).
- for group 1: presence of any of the pre-defined event. ii) CKD IV-V
- any comorbidity / medication which may have an impact on urinary biomarker profile (e.g. liver disease, metabolic disease, vasculitis or other immunological disease other than the pre-defined events).
- for group 1: presence of any of the pre-defined event. iii) Renal transplant patients for group 1: presence of any of the pre-defined event.
- Primary non-function of the renal transplant organ.
- Blood group (AB0) incompatible.
- Detection of donor specific antibody (DSA) positive (panel-reactive antibodies) at time of enrolment.
- any comorbidity / medication which may have an impact on urinary biomarker profile (e.g. liver disease, metabolic disease, vasculitis or other immunological disease) other than the pre-defined events.
- Presence of other transplanted organs or co-transplanted organs.
- Intention to not use a standard maintenance immunosuppression regimen consisting of calcineurin inhibitor (CNI), antimetabolite (mycophenolate or azathioprine), inhibitor of mechanistic target of rapamycin (mTOR) (Sirolimus / Everolimus) with/without corticosteroids.
- Any condition that, in the opinion of the investigator, would pose risk to the subject's safe participation, or interfere with their ability to comply with the study requirements, or may impact the quality of the interpretation of the data (e.g. detection of malignancy).
- Failure to collect urine samples or incomplete additional CERTAIN dataset (for collecting information about pre-defined events).
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT05208788
Start Date
June 1 2021
End Date
February 1 2023
Last Update
November 29 2023
Active Locations (1)
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1
University Children's Hospital Tuebingen
Tübingen, Germany, 72076