A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria

Study Overview
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Brief Summary
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The purpose of the D4325C00007 study is to identify and characterise patients with known or newly diagnosed CKD for possible participation in future renal clinical studies and to obtain an overview on current treatment choices for this patient group in different regions.

Official Title
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An International, Non-randomised, Non-interventional, Multicentre Study to Identify and Characterise Patients With CKD and High Proteinuria for Possible Participation in Future Renal Clinical Studies.

Conditions
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Renal Disease

Intervention / Treatment
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* Procedure: assessment


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female aged ≥ 18 years at the time of signing the informed consent Express interest to participate in a future CKD clinical study eGFR ≥ 20 to < 90 mL/min/1.73 m2 (eGFRcr[AS], Section 8.2.1) (Delgado et al 2022, Inker et al. 2021) UACR ≥ 700 mg/g or UPCR ≥ 1000 mg/g based on urine sample at time of screening visit Receiving RAS inhibitor therapy (ACEi or ARB) that has been at stable dosing for at least 4 weeks. Exceptions from this requirement will be made for participants who are unable to tolerate RAS inhibitor therapy Provision of signed and dated written informed consent before any study-specific procedures Exclusion criteria: Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment Known T1DM Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal) Known history of solid organ transplantation Known history or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin) or endothelin receptor antagonists (eg, ambrisentan, atrasentan, bosentan) Known blood-borne diseases such as specified in Appendix B (category A and B) Known pregnancy at the time for the visit or have an intention to become pregnant Lupus nephritis, anti-neutrophil cytoplasmic autoantibody vasculitis, minimal change disease, autosomal dominant polycystic kidney disease (polycystic kidney disease), Alport syndrome, patients on renal replacement therapy, or clinical nephrotic syndrome with problematic oedema

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: assessment|2 ml volume of blood withdrawal|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with UACR>700mg/g or UPCR >1000mg/g and eGFR 20-90 mL/min/1.73 m2 | Summary statistics | approximately 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and sort of antihypertensive drugs among patients in different geographical regions | Use of medications | approximately 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Proteinuria