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

Chronic Kidney Diseases Clinical Trial

— InspeCKD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05953701
• Other study ID #: D1843R00351
• Status: Completed
• Start date: July 26, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800211
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Germany	Research Site	Koblenz

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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