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| ID | Type | Description | Link |
|---|---|---|---|
| 20230529-3204 | Registry Identifier | Studienregister des LKH - Universitätskliniken Innsbruck | |
| 2024-A00107-40 | Other Identifier | ANSM ID-RCB |
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| Name | Class |
|---|---|
| Medical University Innsbruck | OTHER |
| Klinikum Bayreuth GmbH | INDUSTRY |
| University of Skövde | OTHER |
| RWTH Aachen University |
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The goal of this longitudinal observational study is to estimate the performances of a candidate proteomic biomarker to identify patients at short term risk of chronic kidney disease (CKD) progression, in CKD patients attending nephrology visits in 3 participating centres. The primary endpoint of CKD progression is defined as a relative change in eGFR observed at 1 year below -10%. The performance of the candidate biomarker will be compared to performances of UAE and KFRE equations.
Participants will attend two study visits (baseline and 1-year), with clinical evaluation including kidney parameters (eGFR, urinary albumin excretion (UAE)) and collection of biological samples (plasma, serum, urine) for candidate proteomic biomarker evaluation. If planned in routine, patients will also have creatinine clearance estimation from 24-hour urine collection, kidney echography and kidney biopsy, sample biobanking and/or questionnaires and interviews on social and ethical aspects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD patients | adults with eGFR between 25 and 65 mL/min/1.73m² |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD progression biomarker | Diagnostic Test | We will evaluate the CKD progression biomarker at baseline and evaluate 1-year CKD progression afterwards. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative eGFR change | Difference in eGFR after 1-year divided by baseline eGFR estimated with CKD-EPI formula | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Renal Events (MARE) | Composite endpoint defined by the occurrence of any of the following: worsening of kidney disease (-40% eGFR, doubling of creatinine), ESKD (dialysis therapy or renal transplantation), death of any cause. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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CKD patients attending nephrology medical visits
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| Name | Affiliation | Role |
|---|---|---|
| Angel Argiles | RD Néphrologie, Néphrologie Dialyse St Guilhem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria | |||
| Néphrologie Dialyse St Guilhem |
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| Label | URL |
|---|---|
| Project website | View source |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| OTHER |
| RD Néphrologie SAS | INDUSTRY |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University Paul Sabatier of Toulouse | OTHER |
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Plasma, serum, spot urine, 24-hour collection urine
| Sète |
| 34200 |
| France |
| Klinikum Bayreuth GmbH | Bayreuth | 95445 | Germany |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |