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

Completed

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT05953701
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-20
• Study Start: 2023-07-26
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800211

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
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
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
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 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
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
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
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
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
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
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

Trial Locations

Locations (1)

Research Site; 🇩🇪 Koblenz, Germany