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Completed

NCT Number: NCT05953701

Secondary Data Analysis of Patients at Risk for CKD 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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Koblenz, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years at start of the patient´s observation period
  • 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:
  • Coronary and/or other atherosclerosis
  • Myocardial infarction
  • Heart failure
  • Peripheral arterial disease
  • Arrythmia
  • Stroke
  • Having at least one year (52 weeks) of observation period

Exclusion criteria

NA

Treatment and study plan

Primary outcomes

  1. Percentage of patients with diagnosed CKD

    Time frame: 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

  2. Percentage of patients with undiagnosed CKD

    Time frame: 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

  3. Percentage of patients with undiagnosed or diagnosed CKD

    Time frame: 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

  4. Percentage of patients that fulfil CKD definition according to KDIGO (Kidney Disease: Improving Global Outcomes)

    Time frame: 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 outcomes

  1. Average number of serum creatinine measurements per patient per year (52 weeks) in the study period

    Time frame: 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

  2. Average number of UACR measurements per patient per year (52 weeks) during the study period

    Time frame: 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

  3. Percentage of patients with no, one, or at least two serum creatinine measurements among all eligible patients during the study period

    Time frame: 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

  4. Percentage of patients with no, one, or at least two UACR measurements among all eligible patients during the study period

    Time frame: 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

  5. Percentage of patients who did not have serum creatinine and UACR determined at least once

    Time frame: 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

  6. Percentage of patients in whom both serum creatinine and UACR were determined at least once

    Time frame: 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

  7. Percentage of patients in whom both serum creatinine and UACR were determined at least twice

    Time frame: 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

  8. 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

    Time frame: 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

  9. 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

    Time frame: 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

  10. 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

    Time frame: 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

  11. Age at index date

    Time frame: 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

  12. Sex at index date

    Time frame: 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

  13. BMI at index date

    Time frame: 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

  14. Concurrent medication at index date

    Time frame: 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

  15. Comorbidities at index date

    Time frame: 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

  16. eGFR values at index date

    Time frame: 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

  17. UACR values at index date

    Time frame: 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

  18. 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

    Time frame: 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

  19. 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

    Time frame: 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

  20. Percentage of patients with impaired kidney function

    Time frame: 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

Other outcomes

  1. 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

    Time frame: 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

  2. 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

    Time frame: 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

  3. 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

    Time frame: 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

  4. 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

    Time frame: 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

  5. 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

    Time frame: 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

  6. 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

    Time frame: 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

  7. Time (in weeks) from first fulfilment of CKD definition to coding of ICD-10 code for CKD

    Time frame: 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

  8. Time (in weeks) from CKD diagnosis among priorly undiagnosed patients to first prescription of RASi, SGLT2i, statin or MRA (Finerenone)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: InspeCKD

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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