InspeCKD: Secondary Data Analysis of Patients at Risk for CKD to Inspect CKD Prevalence, Diagnosis Rates, Diagnostic Behaviour, Treatment Patterns and Patient Characteristics
Study Details
Study Description
Brief 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. Furthermore, it addresses the question of how CKD screening, monitoring and treatment of these patients is conducted within the German primary care setting.
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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
Outcome Measures
Primary Outcome Measures
- Percentage of patients with diagnosed CKD [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 [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 [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) [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
Secondary Outcome Measures
- Average number of serum creatinine measurements per patient per year (52 weeks) in the study period [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- Average number of UACR measurements per patient per year (52 weeks) during the study period [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- Percentage of patients with no, one, or at least two serum creatinine measurements among all eligible patients during the study period [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- Percentage of patients with no, one, or at least two UACR measurements among all eligible patients during the study period [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- Percentage of patients who did not have serum creatinine and UACR determined at least once [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- Percentage of patients in whom both serum creatinine and UACR were determined at least once [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- Percentage of patients in whom both serum creatinine and UACR were determined at least twice [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- 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 [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- 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 [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- 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 [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of CKD-related laboratory diagnostics in all eligible patients
- Age at index date [Dating back a maximum of 24 months from the date of first data transfer]
To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date
- Sex at index date [Dating back a maximum of 24 months from the date of first data transfer]
To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date
- BMI at index date [Dating back a maximum of 24 months from the date of first data transfer]
To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date
- Concurrent medication at index date [Dating back a maximum of 24 months from the date of first data transfer]
To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date
- Comorbidities at index date [Dating back a maximum of 24 months from the date of first data transfer]
To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date
- eGFR values at index date [Dating back a maximum of 24 months from the date of first data transfer]
To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date
- UACR values at index date [Dating back a maximum of 24 months from the date of first data transfer]
To describe baseline characteristics among patients with diagnosed and undiagnosed CKD at index date
- 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 [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of medication to treat CKD among patients with diagnosed and undiagnosed CKD
- 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 [Dating back a maximum of 24 months from the date of first data transfer]
To evaluate the use of medication to treat CKD among patients with diagnosed and undiagnosed CKD
- Percentage of patients with impaired kidney function [Dating back a maximum of 24 months from the date of first data transfer]
To assess the prevalence of impaired kidney function in all eligible patients
Other Outcome Measures
- Percentage of patients among patients with diagnosed / undiagnosed CKD with at least one measurement of serum creatinine and UACR once per year (as recommended by KDIGO or ADA) in the study period [Dating back a maximum of 24 months from the date of first data transfer]
To assess guideline adherence and achievement of target values for the use of CKD-related laboratory diagnostics, the use of recommended CKD therapies and therapeutic target values in patients with diagnosed and undiagnosed CKD
- Percentage of patients among patients with diagnosed / undiagnosed CKD that reached target values for blood pressure (as recommended by KDIGO) within 6 month (26 weeks) after index date [Dating back a maximum of 24 months from the date of first data transfer]
To assess guideline adherence and achievement of target values for the use of CKD-related laboratory diagnostics, the use of recommended CKD therapies and therapeutic target values in patients with diagnosed and undiagnosed CKD
- Percentage of patients among patients with diagnosed / undiagnosed CKD with guideline adherent medication as recommended by KDIGO, ADA or DEGAM within 6 month (26 weeks) after index date [Dating back a maximum of 24 months from the date of first data transfer]
To assess guideline adherence and achievement of target values for the use of CKD-related laboratory diagnostics, the use of recommended CKD therapies and therapeutic target values in patients with diagnosed and undiagnosed CKD
- Time (in weeks) from first eGFR value below 60 ml/min/1.73 m2 until the second measurement of eGFR in patients who have a reported second measurement [Dating back a maximum of 24 months from the date of first data transfer]
To assess time from first eGFR value below 60 ml/min/1.73 m2 until a second estimation is performed in all eligible patients
- Time (in weeks) from first UACR value above 30 mg/g until the second measurement of UACR in patients who have a reported second measurement [Dating back a maximum of 24 months from the date of first data transfer]
To assess time from first UACR value above 30 mg/g until a second measurement of UACR is performed in all eligible patients
- Time (in weeks) from first UACR value above 300 mg/g until the second measurement of UACR in patients who have a reported second measurement [Dating back a maximum of 24 months from the date of first data transfer]
To assess time from first UACR value above 300 mg/g until a second measurement of UACR is performed in all eligible patients
- Time (in weeks) from first fulfilment of CKD definition to coding of ICD-10 code for CKD [Dating back a maximum of 24 months from the date of first data transfer]
To assess time from first fulfilment of CKD definition to diagnosis (by ICD-10 code) in all eligible patients
- Time (in weeks) from CKD diagnosis among priorly undiagnosed patients to first prescription of RASi, SGLT2i, statin or MRA (Finerenone) [Dating back a maximum of 24 months from the date of first data transfer]
To assess time from CKD diagnosis in priorly undiagnosed patients to initiation of RASi, SGLT2i, statin or Finerenone therapy
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years at start of the patient´s observation period
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Having at least one of the following diseases (based on the documented ICD-10 code):
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Type 1 diabetes
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Type 2 diabetes
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Hypertension
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Cardiovascular disease, including:
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Coronary and/or other atherosclerosis
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Myocardial infarction
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Heart failure
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Peripheral arterial disease
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Arrythmia
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Stroke
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Having at least one year (52 weeks) of observation period
Exclusion Criteria: NA
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1843R00351