Renal Disease Clinical Trial
Official title:
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.
| NCT number | NCT05967806 |
| Other study ID # | D4325C00007 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 31, 2023 |
| Est. completion date | August 21, 2024 |
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.
| Status | Recruiting |
| Enrollment | 3000 |
| Est. completion date | August 21, 2024 |
| Est. primary completion date | August 21, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Ciudad de Buenos Aires | |
| Argentina | Research Site | Santa Fe | |
| Argentina | Research Site | Santa Fe | |
| Brazil | Research Site | Belem | |
| Brazil | Research Site | Botucatu | |
| Brazil | Research Site | Curitiba | |
| Brazil | Research Site | Fortaleza | |
| Brazil | Research Site | Joinville | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Rio de Janeiro | |
| Brazil | Research Site | Sao Jose Do Rio Preto | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | Sao Paulo | |
| Canada | Research Site | Chicoutimi | |
| Canada | Research Site | Greenfield Park | |
| Canada | Research Site | London | |
| Canada | Research Site | Montreal | |
| Canada | Research Site | Oakville | |
| Canada | Research Site | Sherbrooke | |
| Canada | Research Site | Waterloo | |
| China | Research Site | Baotou | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Chongqing | |
| China | Research Site | Chuangchun | |
| China | Research Site | Deyang | |
| China | Research Site | Foshan | |
| China | Research Site | Fujian | |
| China | Research Site | Guangdong | |
| China | Research Site | Guangdong | |
| China | Research Site | Guangdong | |
| China | Research Site | Guangdong | |
| China | Research Site | Guiyang | |
| China | Research Site | Hengyang | |
| China | Research Site | Hubei | |
| China | Research Site | Hunan | |
| China | Research Site | Hunan | |
| China | Research Site | Jiangsu | |
| China | Research Site | Jiangxi | |
| China | Research Site | Jilin | |
| China | Research Site | Nanchang | |
| China | Research Site | Nanjing | |
| China | Research Site | Nanning | |
| China | Research Site | Pingxiang | |
| China | Research Site | Shanghai | |
| China | Research Site | Shenzhen | |
| China | Research Site | Sichuan | |
| China | Research Site | Sichuan | |
| China | Research Site | Sichuan | |
| China | Research Site | Wenzhou | |
| China | Research Site | Xi'an | |
| China | Research Site | Yantai | |
| China | Research Site | Yinchuan | |
| China | Research Site | Zhejiang | |
| China | Research Site | Zhejiang | |
| China | Research Site | Zhejiang | |
| India | Research Site | Bangalore | |
| India | Research Site | Delhi | |
| India | Research Site | Dhanvantari Nagar | |
| India | Research Site | Nadiad | |
| India | Research Site | New Delhi | |
| India | Research Site | Rajasthan | |
| Mexico | Research Site | Cuernavaca | |
| Mexico | Research Site | Mazatlan | |
| Mexico | Research Site | Mexico | |
| Mexico | Research Site | Veracruz | |
| Philippines | Research Site | Angeles City | |
| Philippines | Research Site | Cainta | |
| Philippines | Research Site | Davao City | |
| Philippines | Research Site | Iloilo City | |
| Philippines | Research Site | Manila | |
| Philippines | Research Site | Quezon City | |
| Poland | Research Site | Bielsko-Biala | |
| Poland | Research Site | Bochnia | |
| Poland | Research Site | Chrzanow | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lezajsk | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Piaseczno | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Radom | |
| Poland | Research Site | Ruda Slaska | |
| Poland | Research Site | Rzeszów | |
| Poland | Research Site | Szczecin | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Tychy | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wroclaw | |
| Slovakia | Research Site | Banska Bystrica | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Lucenec | |
| Slovakia | Research Site | Presov | |
| Slovakia | Research Site | Puchov | |
| Slovakia | Research Site | Roznava | |
| Slovakia | Research Site | Trebisov | |
| South Africa | Research Site | Benoni | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Centurion | |
| South Africa | Research Site | Chatsworth | |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Lenasia | |
| South Africa | Research Site | Parow | |
| South Africa | Research Site | Pretoria | |
| South Africa | Research Site | Soweto | |
| South Africa | Research Site | Soweto | |
| Sweden | Research Site | Goteborg | |
| Sweden | Research Site | Linkoping | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Rattvik | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uppsala | |
| Taiwan | Research Site | 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 | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Chiang Mai | |
| Thailand | Research Site | Khon Kaen | |
| Thailand | Research Site | Songkhla | |
| Turkey | Research Site | Adapazari | |
| Turkey | Research Site | 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 | Mersin | |
| United States | Research Site | Arlington | Virginia |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Chatsworth | California |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Kinston | North Carolina |
| United States | Research Site | Maumee | Ohio |
| United States | Research Site | Miami | Florida |
| United States | Research Site | New Bern | North Carolina |
| United States | Research Site | Pearland | Texas |
| United States | Research Site | S. Gate | California |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Carlos | California |
| United States | Research Site | Sun City West | Arizona |
| United States | Research Site | Tarzana | California |
| United States | Research Site | Victorville | California |
| United States | Research Site | Wilmington | North Carolina |
| United States | Research Site | Winston-Salem | North Carolina |
| Vietnam | Research Site | Ha Noi | |
| Vietnam | Research Site | Hai Phong | |
| Vietnam | Research Site | Ho Chi Minh City |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Vietnam, Argentina, Brazil, Canada, China, India, Mexico, Philippines, Poland, Slovakia, South Africa, Sweden, Taiwan, Thailand, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Number and sort of antihypertensive drugs among patients in different geographical regions | Use of medications | approximately 10 months |
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