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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05953701

Acronym

InspeCKD

Enrollment

800211

Registered

2023-07-20

Start date

2023-07-26

Completion date

2023-09-30

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Diseases, CKD, SGLT2i

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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 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
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 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

Secondary

Measure	Time frame	Description
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
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
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
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
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
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
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
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 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
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 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
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
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

Other

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

Countries

Germany

Outcome results