An International, Non-randomised, Non-interventional, Multicentre Study to Identify and Characterise Patients With CKD and High Proteinuria for Possible Participation in Future Renal Clinical Studies.

CompletadoClinicalTrials.gov

ID: NCT05967806Tipo: OBSERVATIONALInicio: 31 de jul de 2023Fin estimado: 30 de ago de 2024

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

procedure

assessment

2 ml volume of blood withdrawal

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Santa Fe, Argentina

Patrocinadores

PrincipalAstraZeneca

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