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

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ClinicalTrials.gov Identifier: NCT05967806
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : May 1, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment
Renal Disease Procedure: assessment

Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
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.
Actual Study Start Date : July 31, 2023
Estimated Primary Completion Date : August 21, 2024
Estimated Study Completion Date : August 21, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: assessment
    2 ml volume of blood withdrawal

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number and sort of antihypertensive drugs among patients in different geographical regions [ Time Frame: approximately 10 months ]
    Use of medications


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
<3000
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05967806


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05967806    
Other Study ID Numbers: D4325C00007
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: May 1, 2024
Last Verified: April 2024
Keywords provided by AstraZeneca:
High Proteinuria
Additional relevant MeSH terms:
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Proteinuria
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Urination Disorders
Urological Manifestations