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

April 3, 2025 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2575

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
  • Brazil
      • Belem, Brazil
        • Research Site
      • Botucatu, Brazil
        • Research Site
      • Sao Jose Do Rio Preto, Brazil
        • Research Site
      • Sao Paulo, Brazil
        • Research Site
  • Canada
      • London, Canada
        • Research Site
      • Waterloo, Canada
        • Research Site
  • China
      • Beijing, China
        • Research Site
      • Guangdong, China
        • Research Site
      • Hubei, China
        • Research Site
      • Hunan, China
        • Research Site
      • Jiangsu, China
        • Research Site
      • Shenzhen, China
        • Research Site
      • Sichuan, China
        • Research Site
      • Wenzhou, China
        • Research Site
      • Zhejiang, China
        • Research Site
  • India
      • Bangalore, India
        • Research Site
      • Delhi, India
        • Research Site
      • Nadiad, India
        • Research Site
  • Poland
      • Chrzanow, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Radom, Poland
        • Research Site
      • Rzeszów, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
  • Slovakia
      • Kosice, Slovakia
        • Research Site
      • Lucenec, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
      • Puchov, Slovakia
        • Research Site
      • Roznava, Slovakia
        • Research Site
      • Trebisov, Slovakia
        • Research Site
  • South Africa
      • Benoni, South Africa
        • Research Site
      • Chatsworth, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Lenasia, South Africa
        • Research Site
      • Parow, South Africa
        • Research Site
      • Soweto, South Africa
        • Research Site
  • Sweden
      • Linkoping, Sweden
        • Research Site
      • Rattvik, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
  • Taiwan
      • 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, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
      • Khon Kaen, Thailand
        • Research Site
      • Songkhla, Thailand
        • Research Site
  • Turkey
      • 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
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Research Site
    • California
      • Bakersfield, California, United States, 93309
        • Research Site
      • Chatsworth, California, United States, 91311
        • Research Site
      • S. Gate, California, United States, 90280
        • Research Site
      • San Carlos, California, United States, 94070
        • Research Site
      • Tarzana, California, United States, 91356
        • Research Site
      • Victorville, California, United States, 92395
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 28546
        • Research Site
      • Miami, Florida, United States, 33165
        • Research Site
    • North Carolina
      • Kinston, North Carolina, United States, 28504
        • Research Site
      • New Bern, North Carolina, United States, 28562
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 27834
        • Research Site
    • Texas
      • Pearland, Texas, United States, 77584
        • Research Site
      • San Antonio, Texas, United States, 78204
        • Research Site
    • Virginia
      • Arlington, Virginia, United States, 76015
        • Research Site
  • Vietnam
      • Ha Noi, Vietnam
        • Research Site
      • Hai Phong, Vietnam
        • Research Site
      • Ho Chi Minh City, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

<3000

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
approximately 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number and sort of antihypertensive drugs among patients in different geographical regions
Time Frame: approximately 10 months
Use of medications
approximately 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D4325C00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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