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NCT05967806Completed

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

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.

Source: ClinicalTrials.gov · Last updated 6 Apr 2025

Brief summary (registry, in English)

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 (registry)
Completed
Study type
Observational
Enrollment
2575 (actual)
First submitted
20 Jul 2023
Start date
31 Jul 2023
Primary completion date
30 Aug 2024
Lead sponsor
AstraZeneca
NCT number
NCT05967806

What you commit to

  • Study type: Observational
  • Participants enrolled: 2575
  • From 31 Jul 2023 to the primary completion date, 30 Aug 2024
  • 80 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
  • 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)

Lab values

  • 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

Other

  • Known T1DM
  • Known pregnancy at the time for the visit or have an intention to become pregnant

Who the study is looking for

  • 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

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (80)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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Santa FeArgentinaUnknown status
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BelémBrazilUnknown status
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BotucatuBrazilUnknown status
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São José do Rio PretoBrazilUnknown status
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São PauloBrazilUnknown status
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LondonCanadaUnknown status
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WaterlooCanadaUnknown status
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BeijingChinaUnknown status
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GuangdongChinaUnknown status
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HubeiChinaUnknown status
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HunanChinaUnknown status
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JiangsuChinaUnknown status
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ShenzhenChinaUnknown status
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SichuanChinaUnknown status
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WenzhouChinaUnknown status
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ZhejiangChinaUnknown status
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BangaloreIndiaUnknown status
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DelhiIndiaUnknown status
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NadiādIndiaUnknown status
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ChrzanówPolandUnknown status
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KrakowPolandUnknown status
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LodzPolandUnknown status
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RadomPolandUnknown status
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RzeszówPolandUnknown status
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WarsawPolandUnknown status
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LinköpingSwedenUnknown status
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RättvikSwedenUnknown status
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StockholmSwedenUnknown status
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UppsalaSwedenUnknown status
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KošiceSlovakiaUnknown status
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LučenecSlovakiaUnknown status
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PrešovSlovakiaUnknown status
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PúchovSlovakiaUnknown status
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RožňavaSlovakiaUnknown status
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TrebišovSlovakiaUnknown status
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BangkokThailandUnknown status
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Chiang MaiThailandUnknown status
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Khon KaenThailandUnknown status
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SongkhlaThailandUnknown status
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Kaohsiung CityTaiwanUnknown status
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New Taipei CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaoyuanTaiwanUnknown status
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Yongkang DistrictTaiwanUnknown status
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ArlingtonUnited StatesUnknown status
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BakersfieldUnited StatesUnknown status
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ChatsworthUnited StatesUnknown status
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GreenvilleUnited StatesUnknown status
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HuntsvilleUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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KinstonUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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New BernUnited StatesUnknown status
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PearlandUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San CarlosUnited StatesUnknown status
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South GateUnited StatesUnknown status
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TarzanaUnited StatesUnknown status
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VictorvilleUnited StatesUnknown status
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WilmingtonUnited StatesUnknown status
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Winston-SalemUnited StatesUnknown status
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HaiphongVietnamUnknown status
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Hà NộiVietnamUnknown status
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Ho Chi Minh CityVietnamUnknown status
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BenoniSouth AfricaUnknown status
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ChatsworthSouth AfricaUnknown status
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DurbanSouth AfricaUnknown status
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LenasiaSouth AfricaUnknown status
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ParowSouth AfricaUnknown status
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SowetoSouth AfricaUnknown status
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AdapazarıTurkey (Türkiye)Unknown status
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AfyonkarahisarTurkey (Türkiye)Unknown status
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AnkaraTurkey (Türkiye)Unknown status
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AntalyaTurkey (Türkiye)Unknown status
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BursaTurkey (Türkiye)Unknown status
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KahramanmaraşTurkey (Türkiye)Unknown status
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KayseriTurkey (Türkiye)Unknown status
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KocaeliTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.