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

NCT ID: NCT05967806

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2575 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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assessment

2 ml volume of blood withdrawal

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Huntsville, Alabama, United States

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Bakersfield, California, United States

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Chatsworth, California, United States

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San Carlos, California, United States

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South Gate, California, United States

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Tarzana, California, United States

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Victorville, California, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Kinston, North Carolina, United States

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New Bern, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Greenville, South Carolina, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

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Arlington, Virginia, United States

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Buenos Aires, , Argentina

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Santa Fe, , Argentina

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Belém, , Brazil

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Botucatu, , Brazil

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São José do Rio Preto, , Brazil

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São Paulo, , Brazil

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London, , Canada

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Waterloo, , Canada

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Beijing, , China

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Guangdong, , China

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Hubei, , China

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Hunan, , China

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Jiangsu, , China

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Shenzhen, , China

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Sichuan, , China

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Wenzhou, , China

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Zhejiang, , China

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Bangalore, , India

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Delhi, , India

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Nadiād, , India

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Chrzanów, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Radom, , Poland

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Rzeszów, , Poland

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Warsaw, , Poland

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Košice, , Slovakia

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Lučenec, , Slovakia

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Prešov, , Slovakia

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Púchov, , Slovakia

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Rožňava, , Slovakia

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Trebišov, , Slovakia

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Benoni, , South Africa

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Chatsworth, , South Africa

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Durban, , South Africa

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Lenasia, , South Africa

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Parow, , South Africa

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Soweto, , South Africa

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Linköping, , Sweden

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Rättvik, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Kaohsiung City, , Taiwan

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New Taipei City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Yongkang District, , Taiwan

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Khon Kaen, , Thailand

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Songkhla, , Thailand

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Adapazarı, , Turkey (Türkiye)

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Afyonkarahisar, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Bursa, , Turkey (Türkiye)

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Kahramanmaraş, , Turkey (Türkiye)

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Kayseri, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Haiphong, , Vietnam

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Hà Nội, , Vietnam

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Ho Chi Minh City, , Vietnam

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Countries

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United States Argentina Brazil Canada China India Poland Slovakia South Africa Sweden Taiwan Thailand Turkey (Türkiye) Vietnam

Other Identifiers

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D4325C00007

Identifier Type: -

Identifier Source: org_study_id

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