A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- To identify patients meeting UACR and EGFR criteria [approximately 10 months]
Summary statistics
Secondary Outcome Measures
- To obtain an overview on current medication for patients with CKD and high proteinuria across different geographical regions [approximately 10 months]
Use of medications
Eligibility Criteria
Criteria
Inclusion criteria:
-
Male or female aged ≥ 18 years at the time of signing the informed consent
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Express interest to participate in a future CKD clinical study
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eGFR ≥ 20 to < 90 mL/min/1.73 m2 (eGFRcr[AS], Section 8.2.1) (Delgado et al 2022, Inker et al. 2021)
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UACR ≥ 700 mg/g or UPCR ≥ 1000 mg/g based on urine sample at time of screening visit
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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
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Provision of signed and dated written informed consent before any study-specific procedures
Exclusion criteria:
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Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
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Known T1DM
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Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal)
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Known history of solid organ transplantation
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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)
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Known blood-borne diseases such as specified in Appendix B (category A and B)
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Known pregnancy at the time for the visit or have an intention to become pregnant
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Bakersfield | California | United States | 93309 |
| 2 | Research Site | Chatsworth | California | United States | 91311 |
| 3 | Research Site | S. Gate | California | United States | 90280 |
| 4 | Research Site | Tarzana | California | United States | 91356 |
| 5 | Research Site | Victorville | California | United States | 92395 |
| 6 | Research Site | Jacksonville | Florida | United States | 28546 |
| 7 | Research Site | Miami | Florida | United States | 33165 |
| 8 | Research Site | Kinston | North Carolina | United States | 28504 |
| 9 | Research Site | New Bern | North Carolina | United States | 28562 |
| 10 | Research Site | Wilmington | North Carolina | United States | 28401 |
| 11 | Research Site | Greenville | South Carolina | United States | 27834 |
| 12 | Research Site | Arlington | Virginia | United States | 76015 |
| 13 | Research Site | Buenos Aires | Argentina | ||
| 14 | Research Site | Belem | Brazil | ||
| 15 | Research Site | Botucatu | Brazil | ||
| 16 | Research Site | Curitiba | Brazil | ||
| 17 | Research Site | Fortaleza | Brazil | ||
| 18 | Research Site | Joinville | Brazil | ||
| 19 | Research Site | Porto Alegre | Brazil | ||
| 20 | Research Site | Rio de Janeiro | Brazil | ||
| 21 | Research Site | Sao Jose Do Rio Preto | Brazil | ||
| 22 | Research Site | Sao Paulo | Brazil | ||
| 23 | Research Site | Chicoutimi | Canada | ||
| 24 | Research Site | London | Canada | ||
| 25 | Research Site | Montreal | Canada | ||
| 26 | Research Site | Oakville | Canada | ||
| 27 | Research Site | Waterloo | Canada | ||
| 28 | Research Site | Aalborg | Denmark | ||
| 29 | Research Site | Aarhus | Denmark | ||
| 30 | Research Site | Copenhagen | Denmark | ||
| 31 | Research Site | Gentofte | Denmark | ||
| 32 | Research Site | Godstrup | Denmark | ||
| 33 | Research Site | Holbaek | Denmark | ||
| 34 | Research Site | Hvidovre | Denmark | ||
| 35 | Research Site | Roskilde | Denmark | ||
| 36 | Research Site | Cuernavaca, MOR | Mexico | ||
| 37 | Research Site | Veracruz | Mexico | ||
| 38 | Research Site | Almere | Netherlands | ||
| 39 | Research Site | Amersfoort | Netherlands | ||
| 40 | Research Site | Breda | Netherlands | ||
| 41 | Research Site | Dordrecht | Netherlands | ||
| 42 | Research Site | Groningen | Netherlands | ||
| 43 | Research Site | Nieuwegein | Netherlands | ||
| 44 | Research Site | Bodo | Norway | ||
| 45 | Research Site | Lorenskog | Norway | ||
| 46 | Research Site | Oslo | Norway | ||
| 47 | Research Site | Stavanger | Norway | ||
| 48 | Research Site | Tromso | Norway | ||
| 49 | Research Site | Bielsko-Biala | Poland | ||
| 50 | Research Site | Bochnia | Poland | ||
| 51 | Research Site | Chrzanow | Poland | ||
| 52 | Research Site | Krakow | Poland | ||
| 53 | Research Site | Lodz | Poland | ||
| 54 | Research Site | Radom | Poland | ||
| 55 | Research Site | Ruda Slaska | Poland | ||
| 56 | Research Site | Torun | Poland | ||
| 57 | Research Site | Warszawa | Poland | ||
| 58 | Research Site | Wroclaw | Poland | ||
| 59 | Research Site | Kosice | Slovakia | ||
| 60 | Research Site | Lucenec | Slovakia | ||
| 61 | Research Site | Presov | Slovakia | ||
| 62 | Research Site | Puchov | Slovakia | ||
| 63 | Research Site | Roznava | Slovakia | ||
| 64 | Research Site | Trebisov | Slovakia | ||
| 65 | Research Site | Goteborg | Sweden | ||
| 66 | Research Site | Linkoping | Sweden | ||
| 67 | Research Site | Rattvik | Sweden | ||
| 68 | Research Site | Stockholm | Sweden | ||
| 69 | Research Site | Uppsala | Sweden | ||
| 70 | Research Site | Kaohsiung city | Taiwan | ||
| 71 | Research Site | Kaohsiung | Taiwan | ||
| 72 | Research Site | New Taipei | Taiwan | ||
| 73 | Research Site | Taichung | Taiwan | ||
| 74 | Research Site | Taipei City | Taiwan | ||
| 75 | Research Site | Taipei | Taiwan | ||
| 76 | Research Site | Taoyuan | Taiwan | ||
| 77 | Research Site | Yong Kang City | Taiwan | ||
| 78 | Research Site | Bangkok | Thailand | ||
| 79 | Research Site | Khon Kaen | Thailand | ||
| 80 | Research Site | Muang | Thailand | ||
| 81 | Research Site | Songkhla | Thailand | ||
| 82 | Research Site | Adapazari | Turkey | ||
| 83 | Research Site | Ankara | Turkey | ||
| 84 | Research Site | Antalya | Turkey | ||
| 85 | Research Site | Kahramanmaras | Turkey | ||
| 86 | Research Site | Kayseri | Turkey | ||
| 87 | Research Site | Kocaeli | Turkey | ||
| 88 | Research Site | Ho Chi Minh City | Vietnam |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D4325C00007