Renal Disease
Conditions
Keywords
High Proteinuria
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.
Interventions
PROCEDUREassessment
2 ml volume of blood withdrawal
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with UACR>700mg/g or UPCR >1000mg/g and eGFR 20-90 mL/min/1.73 m2 | approximately 10 months | Summary statistics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and sort of antihypertensive drugs among patients in different geographical regions | approximately 10 months | Use of medications |
Countries
Argentina, Brazil, Canada, China, India, Poland, Slovakia, South Africa, Sweden, Taiwan, Thailand, Turkey (Türkiye), United States, Vietnam
Outcome results
None listed