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

AstraZeneca AB4 sites in 1 country3,000 target enrollmentStarted: August 10, 2024Last updated: August 29, 2024

Overview

Phase: Not Applicable
Status: Not yet recruiting
Sponsor: AstraZeneca AB
Enrollment: 3,000
Locations: 4
Primary Endpoint: To identify and characterise patients with CKD and high proteinuria. Below parameters are assessed.

Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

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. This non- interventional study will aim to identify patients

fulfilling the following eGFR and UACR criteria:

eGFR â‰¥ 20 to < 90 mL/min/1.73 m2

UACR â‰¥ 700 mg/g or UPCR â‰¥ 1000 mg/g

Low eGFR and proteinuria are key markers of kidney disease and results will be shared with the patient and their treating physician.

Study Design

Study Type: Observational

Eligibility Criteria

Ages: 18.00 Year(s) to 99.00 Year(s) (—)
Sex: All

Inclusion Criteria

•1 Male or female aged greater than or equal to 18 years at the time of signing the informed consent 2 Express interest to participate in a future CKD clinical study 3 eGFR greater than or equal to 20 to less than 90 mL/ min/ 1.73 m square (eGFRcr[AS], Section 8.2.1) (Delgado et al 2022, Inker et al.
•4 UACR greater than or equal to 700 mg/g or UPCR greater than or equal to 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 As per investigator judgement, patients who are not suitable and/or stable enough to participate in a phase 3 interventional study (eg, recent hospitalisation for HF, recent cardiac surgery or intervention, heart disease including stroke, life expectancy less than 2 years due to conditions other than renal or CV conditions, unable to commit for personal reasons to a phase 3 trial for up to 4 years) 3 Known T1DM 4 Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal) 5 Known history of solid organ transplantation 6 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) 7 Known blood-borne diseases such as specified in Appendix B (category A and B) 8 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 9 Inability of the patient, in the opinion of the investigator, to understand and/or comply procedures and/or follow-up or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study 10 Known pregnancy at the time for the visit or have an intention to become pregnant 11 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 12 Unable to commit for personal reasons to a phase 3 clinical trial of up to 4 years duration.