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.
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.
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.
- Conditions
- Chronic Kidney Diseases
- 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.
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted20 Jul 2023
- Study start26 Jul 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Retrospective
- Enrolment
- 800,211 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05953701
- Acronym / sponsor ID
- InspeCKD / D1843R00351
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Diseases, CKD, SGLT2i
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800,211 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 Jul 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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adult patients with type 1 diabetes, type 2 diabetes and/or hypertension and/or cardiovascular disease
Key inclusion criteria (13 listed)
- 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):
- Having at least one year (52 weeks) of observation period
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with diagnosed CKD
Time frame: Dating back a maximum of 24 months from the date of first data transfer
To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD
Percentage of patients with undiagnosed CKD
Time frame: Dating back a maximum of 24 months from the date of first data transfer
To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD
Percentage of patients with undiagnosed or diagnosed CKD
Time frame: Dating back a maximum of 24 months from the date of first data transfer
To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD
Percentage of patients that fulfil CKD definition according to KDIGO (Kidney Disease: Improving Global Outcomes)
Time frame: Dating back a maximum of 24 months from the date of first data transfer
To assess the prevalence of diagnosed and undiagnosed CKD among all eligible patients at high risk for the development and progression of CKD
20 secondary outcomes
Average number of serum creatinine measurements per patient per year (52 weeks) in the study period
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Average number of UACR measurements per patient per year (52 weeks) during the study period
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Percentage of patients with no, one, or at least two serum creatinine measurements among all eligible patients during the study period
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Percentage of patients with no, one, or at least two UACR measurements among all eligible patients during the study period
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Percentage of patients who did not have serum creatinine and UACR determined at least once
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Percentage of patients in whom both serum creatinine and UACR were determined at least once
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Percentage of patients in whom both serum creatinine and UACR were determined at least twice
Time frame: Dating back a maximum of 24 months from the date of first data transfer
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
Time frame: Dating back a maximum of 24 months from the date of first data transfer
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
Time frame: Dating back a maximum of 24 months from the date of first data transfer
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
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Age at index date
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Sex at index date
Time frame: Dating back a maximum of 24 months from the date of first data transfer
BMI at index date
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Concurrent medication at index date
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Comorbidities at index date
Time frame: Dating back a maximum of 24 months from the date of first data transfer
eGFR values at index date
Time frame: Dating back a maximum of 24 months from the date of first data transfer
UACR values at index date
Time frame: Dating back a maximum of 24 months from the date of first data transfer
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
Time frame: Dating back a maximum of 24 months from the date of first data transfer
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
Time frame: Dating back a maximum of 24 months from the date of first data transfer
Percentage of patients with impaired kidney function
Time frame: Dating back a maximum of 24 months from the date of first data transfer
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 19 Mar 2025.
- redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
1 site in 1 country: see every site and its status.
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?
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.