Clinical trial NCT05967806: A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Disease
Keywords: High Proteinuria
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 2575
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: \<3000

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with UACR>700mg/g or UPCR >1000mg/g and eGFR 20-90 mL/min/1.73 m2
timeFrame: approximately 10 months
Secondary outcomes:
measure: Number and sort of antihypertensive drugs among patients in different geographical regions
timeFrame: approximately 10 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Chatsworth
country: United States
facility: Research Site
state: California
city: S. Gate
country: United States
facility: Research Site
state: California
city: San Carlos
country: United States
facility: Research Site
state: California
city: Tarzana
country: United States
facility: Research Site
state: California
city: Victorville
country: United States
facility: Research Site
state: California
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Kinston
country: United States
facility: Research Site
state: North Carolina
city: New Bern
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Pearland
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Arlington
country: United States
facility: Research Site
state: Virginia
city: Buenos Aires
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Belem
country: Brazil
facility: Research Site
city: Botucatu
country: Brazil
facility: Research Site
city: Sao Jose Do Rio Preto
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: London
country: Canada
facility: Research Site
city: Waterloo
country: Canada
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Guangdong
country: China
facility: Research Site
city: Hubei
country: China
facility: Research Site
city: Hunan
country: China
facility: Research Site
city: Jiangsu
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Sichuan
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Zhejiang
country: China
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Nadiad
country: India
facility: Research Site
city: Chrzanow
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Radom
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Puchov
country: Slovakia
facility: Research Site
city: Roznava
country: Slovakia
facility: Research Site
city: Trebisov
country: Slovakia
facility: Research Site
city: Benoni
country: South Africa
facility: Research Site
city: Chatsworth
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Lenasia
country: South Africa
facility: Research Site
city: Parow
country: South Africa
facility: Research Site
city: Soweto
country: South Africa
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Rattvik
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Kaohsiung city
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: New Taipei
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Yongkang
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Songkhla
country: Thailand
facility: Research Site
city: Adapazari
country: Turkey
facility: Research Site
city: Afyonkarahisar
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Kahramanmaras
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Ha Noi
country: Vietnam
facility: Research Site
city: Hai Phong
country: Vietnam
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
Study officials:
References: