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

NCT ID: NCT05953701

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800211 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2023-09-30

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.

Conditions

Chronic Kidney Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Koblenz, , Germany

Countries

Germany

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1843R00351&attachmentIdentifier=11d1d349-a28f-4018-bd7d-242cf8ec3d9f&fileName=D1843R00351_Redacted_CSR_Synopsis.pdf&versionIdentifier=

redacted CSR Synopsis

Other Identifiers

D1843R00351

Identifier Type: -

Identifier Source: org_study_id