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

NCT05967806 | Completed

• 1 other identifier: D4325C00007
• Study Type: observational
• Target: 2,575
• Locations: 14 countries
• Sites: 80

Brief 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.

Conditions

Renal Disease

Keywords

High Proteinuria

Outcome Measures

Primary Outcomes (1)

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

  Summary statistics

  approximately 10 months

Secondary Outcomes (1)

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

  approximately 10 months

Interventions

assessment PROCEDURE

2 ml volume of blood withdrawal

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

\<3000

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (80)

Research Site

Huntsville, Alabama, 35805, United States

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Bakersfield, California, 93309, United States

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Chatsworth, California, 91311, United States

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San Carlos, California, 94070, United States

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South Gate, California, 90280, United States

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Tarzana, California, 91356, United States

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Victorville, California, 92395, United States

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Jacksonville, Florida, 28546, United States

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Miami, Florida, 33165, United States

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Kinston, North Carolina, 28504, United States

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New Bern, North Carolina, 28562, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Greenville, South Carolina, 27834, United States

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Pearland, Texas, 77584, United States

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San Antonio, Texas, 78204, United States

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Arlington, Virginia, 76015, 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

Location

Related Links

• D4325C00007\_redacted CSR synopsis-exploratory-study-report-abbreviated\_redacted

MeSH Terms

Conditions

Kidney Diseases

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: July 31, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-02

Locations

US (17); TH (4); TU (8); CA (2); IN (3); SE (4); TW (6); AR (2); ZA (6); VN (3); CN (9); BR (4); PL (6); SL (6)