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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases

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 Type: Observational
• Enrollment (Actual): 800211

Contacts and Locations

Study Locations

• Germany
  • Koblenz, Germany
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Dating back a maximum of 24 months from the date of first data transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Dating back a maximum of 24 months from the date of first data transfer

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Dating back a maximum of 24 months from the date of first data transfer
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	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	Dating back a maximum of 24 months from the date of first data transfer
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	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	Dating back a maximum of 24 months from the date of first data transfer
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	To assess time from first eGFR value below 60 ml/min/1.73 m2 until a second estimation is performed in all eligible patients	Dating back a maximum of 24 months from the date of first data transfer
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	To assess time from first UACR value above 30 mg/g until a second measurement of UACR is performed in all eligible patients	Dating back a maximum of 24 months from the date of first data transfer
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	To assess time from first UACR value above 300 mg/g until a second measurement of UACR is performed in all eligible patients	Dating back a maximum of 24 months from the date of first data transfer
Time (in weeks) from first fulfilment of CKD definition to coding of ICD-10 code for CKD	To assess time from first fulfilment of CKD definition to diagnosis (by ICD-10 code) in all eligible patients	Dating back a maximum of 24 months from the date of first data transfer
Time (in weeks) from CKD diagnosis among priorly undiagnosed patients to first prescription of RASi, SGLT2i, statin or MRA (Finerenone)	To assess time from CKD diagnosis in priorly undiagnosed patients to initiation of RASi, SGLT2i, statin or Finerenone therapy	Dating back a maximum of 24 months from the date of first data transfer

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• redacted CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: CKD; SGLT2i; Chronic Kidney Diseases
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: D1843R00351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved, AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure