A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria
NCT ID: NCT05967806
Last Updated: 2025-04-06
Study Results
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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COMPLETED
2575 participants
OBSERVATIONAL
2023-07-31
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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assessment
2 ml volume of blood withdrawal
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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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
Countries
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Related Links
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D4325C00007\_redacted CSR synopsis-exploratory-study-report-abbreviated\_redacted
Other Identifiers
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D4325C00007
Identifier Type: -
Identifier Source: org_study_id
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