A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria (NCT05967806) | Clinical Trial Compass
CompletedNot Applicable
A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria
United States2,575 participantsStarted 2023-07-31
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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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)
What they're measuring
1
Number of patients with UACR>700mg/g or UPCR >1000mg/g and eGFR 20-90 mL/min/1.73 m2