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

April 3, 2025 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2575

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
  • Brazil
      • Belem, Brazil
        • Research Site
      • Botucatu, Brazil
        • Research Site
      • Sao Jose Do Rio Preto, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Canada
      • London, Canada
        • Research Site
      • Waterloo, Canada
        • Research Site
  • China
      • Beijing, China
        • Research Site
      • Guangdong, China
        • Research Site
      • Hubei, China
        • Research Site
      • Hunan, China
        • Research Site
      • Jiangsu, China
        • Research Site
      • Shenzhen, China
        • Research Site
      • Sichuan, China
        • Research Site
      • Wenzhou, China
        • Research Site
      • Zhejiang, China
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Delhi, India
        • Research Site
      • Nadiad, India
        • Research Site
  • Poland
      • Chrzanow, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Radom, Poland
        • Research Site
      • Rzeszów, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Slovakia
      • Kosice, Slovakia
        • Research Site
      • Lucenec, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
      • Puchov, Slovakia
        • Research Site
      • Roznava, Slovakia
        • Research Site
      • Trebisov, Slovakia
        • Research Site
  • South Africa
      • Benoni, South Africa
        • Research Site
      • Chatsworth, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Lenasia, South Africa
        • Research Site
      • Parow, South Africa
        • Research Site
      • Soweto, South Africa
        • Research Site
  • Sweden
      • Linkoping, Sweden
        • Research Site
      • Rattvik, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Kaohsiung city, Taiwan
        • Research Site
      • New Taipei, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Taipei City, Taiwan
        • Research Site
      • Taoyuan, Taiwan
        • Research Site
      • Yongkang, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
      • Khon Kaen, Thailand
        • Research Site
      • Songkhla, Thailand
        • Research Site
  • Turkey
      • Adapazari, Turkey
        • Research Site
      • Afyonkarahisar, Turkey
        • Research Site
      • Ankara, Turkey
        • Research Site
      • Antalya, Turkey
        • Research Site
      • Bursa, Turkey
        • Research Site
      • Kahramanmaras, Turkey
        • Research Site
      • Kayseri, Turkey
        • Research Site
      • Kocaeli, Turkey
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Research Site
    • California
      • Bakersfield, California, United States, 93309
        • Research Site
      • Chatsworth, California, United States, 91311
        • Research Site
      • S. Gate, California, United States, 90280
        • Research Site
      • San Carlos, California, United States, 94070
        • Research Site
      • Tarzana, California, United States, 91356
        • Research Site
      • Victorville, California, United States, 92395
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 28546
        • Research Site
      • Miami, Florida, United States, 33165
        • Research Site
    • North Carolina
      • Kinston, North Carolina, United States, 28504
        • Research Site
      • New Bern, North Carolina, United States, 28562
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 27834
        • Research Site
    • Texas
      • Pearland, Texas, United States, 77584
        • Research Site
      • San Antonio, Texas, United States, 78204
        • Research Site
    • Virginia
      • Arlington, Virginia, United States, 76015
        • Research Site
  • Vietnam
      • Ha Noi, Vietnam
        • Research Site
      • Hai Phong, Vietnam
        • Research Site
      • Ho Chi Minh City, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

<3000

Description

Inclusion criteria:

  1. Male or female aged ≥ 18 years at the time of signing the informed consent
  2. Express interest to participate in a future CKD clinical study
  3. eGFR ≥ 20 to < 90 mL/min/1.73 m2 (eGFRcr[AS], Section 8.2.1) (Delgado et al 2022, Inker et al. 2021)
  4. UACR ≥ 700 mg/g or UPCR ≥ 1000 mg/g based on urine sample at time of screening visit
  5. 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
  6. Provision of signed and dated written informed consent before any study-specific procedures

Exclusion criteria:

  1. Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
  2. Known T1DM
  3. Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal)
  4. Known history of solid organ transplantation
  5. 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)
  6. Known blood-borne diseases such as specified in Appendix B (category A and B)
  7. Known pregnancy at the time for the visit or have an intention to become pregnant
  8. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
approximately 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and sort of antihypertensive drugs among patients in different geographical regions
Time Frame: approximately 10 months
Use of medications
approximately 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4325C00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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