Clinical trial NCT05953701: Secondary Data Analysis of Patients at Risk for CKD to Inspect CKD Prevalence, Diagnosis Rates, Diagnostic Behaviour, Treatment Patterns and Patient Characteristics
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Diseases
CKD
SGLT2i
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 800211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes adult patients with type 1 diabetes, type 2 diabetes and/or hypertension and/or cardiovascular disease

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years at start of the patient´s observation period
2. 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:

     1. Coronary and/or other atherosclerosis
     2. Myocardial infarction
     3. Heart failure
     4. Peripheral arterial disease
     5. Arrythmia
     6. Stroke
3. Having at least one year (52 weeks) of observation period

Exclusion Criteria: NA

Primary outcomes:
measure: Percentage of patients with diagnosed CKD
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Percentage of patients with undiagnosed CKD
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Percentage of patients with undiagnosed or diagnosed CKD
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Percentage of patients that fulfil CKD definition according to KDIGO (Kidney Disease: Improving Global Outcomes)
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
Secondary outcomes:
measure: Average number of serum creatinine measurements per patient per year (52 weeks) in the study period
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Average number of UACR measurements per patient per year (52 weeks) during the study period
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Percentage of patients with no, one, or at least two serum creatinine measurements among all eligible patients during the study period
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Percentage of patients with no, one, or at least two UACR measurements among all eligible patients during the study period
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Percentage of patients who did not have serum creatinine and UACR determined at least once
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Percentage of patients in whom both serum creatinine and UACR were determined at least once
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Percentage of patients in whom both serum creatinine and UACR were determined at least twice
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Age at index date
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Sex at index date
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: BMI at index date
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Concurrent medication at index date
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Comorbidities at index date
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: eGFR values at index date
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: UACR values at index date
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Percentage of patients with impaired kidney function
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
Other outcomes:
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: 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
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Time (in weeks) from first fulfilment of CKD definition to coding of ICD-10 code for CKD
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
measure: Time (in weeks) from CKD diagnosis among priorly undiagnosed patients to first prescription of RASi, SGLT2i, statin or MRA (Finerenone)
timeFrame: Dating back a maximum of 24 months from the date of first data transfer
Locations:
city: Koblenz
country: Germany
facility: Research Site
Study officials:
References: