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OpenTrials
Completed

NCT Number: NCT05967806

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

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.

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Key information

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

assessment

Procedure

2 ml volume of blood withdrawal

Primary outcomes

  1. Number of patients with UACR>700mg/g or UPCR >1000mg/g and eGFR 20-90 mL/min/1.73 m2

    Time frame: approximately 10 months

    Summary statistics

Secondary outcomes

  1. Number and sort of antihypertensive drugs among patients in different geographical regions

    Time frame: approximately 10 months

    Use of medications

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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