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Chronic Kidney DiseasesInspeCKDNCT05953701

Secondary Data Analysis of Patients at Risk for CKD to Inspect CKD Prevalence, Diagnosis Rates, Diagnostic Behaviour, Treatment Patterns and Patient Characteristics

An observational study of Chronic Kidney Diseases, run by AstraZeneca at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a national secondary data analysis to determine the prevalence of diagnosed and undiagnosed CKD in German primary care offices in a patient population at high risk for the development and progression of CKD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Diseases
How many people
800,211 participants
Where
1 siteGermany
Study dates
26 Jul 2023to 30 Sep 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study includes adult patients with type 1 diabetes, type 2 diabetes and/or hypertension and/or cardiovascular disease

Who may be able to join

  • Age ≥ 18 years at start of the patient´s observation period
  • Having at least one of the following diseases (based on the documented ICD-10 code):
  • Type 1 diabetes
  • Type 2 diabetes
  • Hypertension
  • Cardiovascular disease, including:
Show all 13Show fewer
  • Coronary and/or other atherosclerosis
  • Myocardial infarction
  • Heart failure
  • Peripheral arterial disease
  • Arrythmia
  • Stroke
  • Having at least one year (52 weeks) of observation period

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Research Site

    Koblenz

Other trials in Germany

About this study

Official title: InspeCKD - Secondary Data Analysis of Patients at Risk for Chronic Kidney Disease (CKD) in German Primary Care Offices to Inspect CKD Prevalence, Diagnosis Rates, Diagnostic Behaviour, Treatment Patterns and Patient Characteristics

This study is a national secondary data analysis to determine the prevalence of diagnosed and undiagnosed CKD in German primary care offices in a patient population at high risk for the development and progression of CKD. Furthermore, it addresses the question of how CKD screening, monitoring and treatment of these patients is conducted within the German primary care setting.

Read the detailed description

The study does not attempt to test any specific a priori hypothesis; it is descriptive only. Data on general patient characteristics, health insurance details, participation in disease management programs and/or family doctor-centred care, diagnoses, prescriptions, surgeries, and procedures, used billable services and laboratory test results are documented during daily routine by the physician. The data used in this setting are part of routine visits, dating back a maximum of 24 months from the date of first data transfer within the study period.

Keywords
Chronic Kidney Diseases, CKD, SGLT2i
Medical subject headings
Renal Insufficiency, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with diagnosed CKD

    To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  2. Percentage of patients with undiagnosed CKD

    To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  3. Percentage of patients with undiagnosed or diagnosed CKD

    To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  4. Percentage of patients that fulfil CKD definition according to KDIGO (Kidney Disease: Improving Global Outcomes)

    To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD

    Measured: Dating back a maximum of 24 months from the date of first data transfer

Secondary outcomes (20)

  1. Average number of serum creatinine measurements per patient per year (52 weeks) in the study period

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  2. Average number of UACR measurements per patient per year (52 weeks) during the study period

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  3. Percentage of patients with no, one, or at least two serum creatinine measurements among all eligible patients during the study period

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  4. Percentage of patients with no, one, or at least two UACR measurements among all eligible patients during the study period

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  5. Percentage of patients who did not have serum creatinine and UACR determined at least once

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  6. Percentage of patients in whom both serum creatinine and UACR were determined at least once

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  7. Percentage of patients in whom both serum creatinine and UACR were determined at least twice

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  8. Percentage of patients with at least two serum creatinine measurements with an interval of at least three months among all eligible patients in the study period

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  9. Percentage of patients with at least two UACR measurements with an interval of at least three months among all eligible patients in the study period

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  10. Percentage of patients with at least two UACR and serum creatinine measurements with an interval of at least three months among all eligible patients in the study period

    To evaluate the use of CKD-related laboratory diagnostics in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  11. Age at index date

    To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  12. Sex at index date

    To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  13. BMI at index date

    To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  14. Concurrent medication at index date

    To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  15. Comorbidities at index date

    To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  16. eGFR values at index date

    To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  17. UACR values at index date

    To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  18. Percentage of patients among diagnosed or undiagnosed CKD patients that are treated with either/or renin-angiotensin-system-inhibitors (ACEi, ARB), SGLT2i, statin or selective mineralocorticoid receptor antagonist at index date

    To evaluate the use of medication to treat CKD among patients with diagnosed and undiagnosed CKD

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  19. Percentage of patients among diagnosed or undiagnosed CKD patients that are newly initiated with either/or renin-angiotensin-system-inhibitors (ACEi, ARB), SGLT2i, statin, selective mineralocorticoid receptor antagonist within 6 months after index date

    To evaluate the use of medication to treat CKD among patients with diagnosed and undiagnosed CKD

    Measured: Dating back a maximum of 24 months from the date of first data transfer

  20. Percentage of patients with impaired kidney function

    To assess the prevalence of impaired kidney function in all eligible patients

    Measured: Dating back a maximum of 24 months from the date of first data transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2023
  2. Study start26 Jul 2023
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

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
Retrospective
Enrolment
800,211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05953701
Sponsor's protocol ID
D1843R00351
Acronym
InspeCKD
Status last verified
Mar 2025
First submitted
28 Jun 2023
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes indicates that AZ is accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Diseases, run by AstraZeneca at 1 site in Germany.

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 13 inclusion and 0 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Percentage of patients with diagnosed CKD (time frame: Dating back a maximum of 24 months from the date of first data transfer). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05953701.

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 19 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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