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

Completed

Conditions studied: Renal Disease

In brief

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.

Key facts

Study ID: NCT05967806
Run by: AstraZeneca
People needed: 2575
Starts: 2023-07-31
Expected to finish: 2024-08-30
Last updated by the study team: 2025-04-06

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Hà Nội, Vietnam
Research Site — Ho Chi Minh City, Vietnam
Research Site — Huntsville, Alabama, United States
Research Site — Bakersfield, California, United States
Research Site — Chatsworth, California, United States
Research Site — San Carlos, California, United States
Research Site — South Gate, California, United States
Research Site — Tarzana, California, United States
Research Site — Victorville, California, United States
Research Site — Jacksonville, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Kinston, North Carolina, United States
Research Site — New Bern, North Carolina, United States
Research Site — Wilmington, North Carolina, United States
Research Site — Winston-Salem, North Carolina, United States
Research Site — Greenville, South Carolina, United States
Research Site — Pearland, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — Arlington, Virginia, United States
Research Site — Buenos Aires, Argentina
Research Site — Santa Fe, Argentina
Research Site — Belém, Brazil
Research Site — Botucatu, Brazil
Research Site — São José do Rio Preto, Brazil
Research Site — Haiphong, Vietnam

Full record on ClinicalTrials.gov

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