Status:
COMPLETED
A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria
Lead Sponsor:
AstraZeneca
Conditions:
Renal Disease
Eligibility:
All Genders
18-130 years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 31 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
2575 Patients enrolled
Trial Details
Trial ID
NCT05967806
Start Date
July 31 2023
End Date
August 30 2024
Last Update
April 6 2025
Active Locations (80)
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1
Research Site
Huntsville, Alabama, United States, 35805
2
Research Site
Bakersfield, California, United States, 93309
3
Research Site
Chatsworth, California, United States, 91311
4
Research Site
San Carlos, California, United States, 94070