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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.
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.
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| 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 |
| 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 |
| 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 |
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:
Having at least one year (52 weeks) of observation period
Exclusion Criteria: NA
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This study includes adult patients with type 1 diabetes, type 2 diabetes and/or hypertension and/or cardiovascular disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Koblenz | Germany |
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| Label | URL |
|---|---|
| redacted CSR Synopsis | View source |
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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.
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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.
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
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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 |
| 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 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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