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

AstraZeneca

Status: Enrolling

Conditions: Renal Disease

Treatments: Procedure: assessment

Study type: Observational

Funder types: Industry

Identifiers

NCT05967806

D4325C00007

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female aged ≥ 18 years at the time of signing the informed consent
2. Express interest to participate in a future CKD clinical study
3. eGFR ≥ 20 to < 90 mL/min/1.73 m2 (eGFRcr[AS], Section 8.2.1) (Delgado et al 2022, Inker et al. 2021)
4. UACR ≥ 700 mg/g or UPCR ≥ 1000 mg/g based on urine sample at time of screening visit
5. 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
6. Provision of signed and dated written informed consent before any study-specific procedures

Exclusion criteria

1. Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
2. Known T1DM
3. Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal)
4. Known history of solid organ transplantation
5. 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)
6. Known blood-borne diseases such as specified in Appendix B (category A and B)
7. Known pregnancy at the time for the visit or have an intention to become pregnant
8. 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