Renal DiseaseNCT05967806
A Study to Identify and Characterise Patients With Chronic Kidney Disease and Proteinuria
An observational study of Renal Disease, run by AstraZeneca at 80 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Renal Disease
- What is being tested?
- assessment
- Type of treatment
- Surgery or procedure
- How many people
- 2,575 participants
- Where
- 80 sitesin 14 countries
- Study dates
- 31 Jul 2023to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: <3000
Who may be able to join
- 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
Who cannot join
- Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
- Known T1DM
- 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)
- Known pregnancy at the time for the visit or have an intention to become pregnant
- 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
Trial locations and contacts
80 sites in 14 countries.
80 sites in 14 countries
United States17 sites
Research Site
Arlington, Virginia, 76015
Research Site
Bakersfield, California, 93309
Research Site
Chatsworth, California, 91311
Research Site
Greenville, South Carolina, 27834
Research Site
Huntsville, Alabama, 35805
Research Site
Jacksonville, Florida, 28546
Research Site
Kinston, North Carolina, 28504
Research Site
Miami, Florida, 33165
Research Site
New Bern, North Carolina, 28562
Research Site
Pearland, Texas, 77584
Research Site
San Antonio, Texas, 78204
Research Site
San Carlos, California, 94070
Research Site
South Gate, California, 90280
Research Site
Tarzana, California, 91356
Research Site
Victorville, California, 92395
Research Site
Wilmington, North Carolina, 28401
Research Site
Winston-Salem, North Carolina, 27103
China9 sites
Research Site
Beijing
Research Site
Guangdong
Research Site
Hubei
Research Site
Hunan
Research Site
Jiangsu
Research Site
Shenzhen
Research Site
Sichuan
Research Site
Wenzhou
Research Site
Zhejiang
Turkey (Türkiye)8 sites
Research Site
Adapazarı
Research Site
Afyonkarahisar
Research Site
Ankara
Research Site
Antalya
Research Site
Bursa
Research Site
Kahramanmaraş
Research Site
Kayseri
Research Site
Kocaeli
Poland6 sites
Research Site
Chrzanów
Research Site
Krakow
Research Site
Lodz
Research Site
Radom
Research Site
Rzeszów
Research Site
Warsaw
Slovakia6 sites
Research Site
Košice
Research Site
Lučenec
Research Site
Prešov
Research Site
Púchov
Research Site
Rožňava
Research Site
Trebišov
South Africa6 sites
Research Site
Benoni
Research Site
Chatsworth
Research Site
Durban
Research Site
Lenasia
Research Site
Parow
Research Site
Soweto
Taiwan6 sites
Research Site
Kaohsiung City
Research Site
New Taipei City
Research Site
Taichung
Research Site
Taipei
Research Site
Taoyuan
Research Site
Yongkang District
Brazil4 sites
Research Site
Belém
Research Site
Botucatu
Research Site
São José do Rio Preto
Research Site
São Paulo
Sweden4 sites
Research Site
Linköping
Research Site
Rättvik
Research Site
Stockholm
Research Site
Uppsala
Thailand4 sites
Research Site
Bangkok
Research Site
Chiang Mai
Research Site
Khon Kaen
Research Site
Songkhla
Vietnam3 sites
Research Site
Hà Nội
Research Site
Haiphong
Research Site
Ho Chi Minh City
About this study
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.
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.
- Conditions
- Renal Disease
- Being tested
- assessment
- Keywords
- High Proteinuria
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentProcedure or surgery
2 ml volume of blood withdrawal
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with UACR>700mg/g or UPCR >1000mg/g and eGFR 20-90 mL/min/1.73 m2
Summary statistics
Measured: approximately 10 months
Secondary outcomes (1)
Number and sort of antihypertensive drugs among patients in different geographical regions
Use of medications
Measured: approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start31 Jul 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,575 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967806
- Sponsor's protocol ID
- D4325C00007
- Status last verified
- Feb 2025
- First submitted
- 20 Jul 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05967806
- Acronym / sponsor ID
- D4325C00007
- Conditions
- Renal Disease
- Keywords
- High Proteinuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,575 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- <3000
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment
- Known T1DM
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment2 ml volume of blood withdrawal | Procedure or surgery | – |
Primary outcome
Number of patients with UACR>700mg/g or UPCR >1000mg/g and eGFR 20-90 mL/min/1.73 m2
Time frame: approximately 10 months
Summary statistics
1 secondary outcome
Number and sort of antihypertensive drugs among patients in different geographical regions
Time frame: approximately 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- D4325C00007\_redacted CSR synopsis-exploratory-study-report-abbreviated\_redactedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
80 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Disease, run by AstraZeneca at 80 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, China, Turkey (Türkiye), Poland, Slovakia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with UACR>700mg/g or UPCR >1000mg/g and eGFR 20-90 mL/min/1.73 m2 (time frame: approximately 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.