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The objectives of this analysis is to determine the incidence of anemia occurring in patients with chronic kidney disease (CKD) in primary care (i.e. prior to any eventual referral to nephrology care). This analysis also evaluates patient characteristics, anemia treatment and associated cardiovascular risk.
Data will be derived from the Stockholm CREATinine Measurement (SCREAM) cohort, a repository of laboratory data of individuals residing and accessing healthcare in the region of Stockholm and who underwent a creatinine assessment between 2012 - 2018.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-dialysis dependent patients with CKD stage 3-5 | A cohort of patients will be created from the Stockholm CREAtinine Measurement (SCREAM) cohort based on the eligibility criteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of anemia in adults with non-dialysis dependent CKD stage 3-5 in primary care | Anemia will be defined as the composite of: a diagnosis of anemia, a haemoglobin (Hb) measurement within the defined range for anemia followed by iron (oral or intravenous [IV]) or erythropoietin-simulating agent (ESA) treatment within 3 months, a Hb measurement within the defined range for anemia followed by another low Hb measurement >3 months apart. Anemia as an outcome will be defined by current World Health Organization (WHO) definitions (Hb < 12 g/dL or 7.45 mmol/L for female and < 13 g/dL or 8.07 mmol/L for male). The incidence rate of anemia will be calculated as the number of new cases divided by person-time of CKD stage 3-5 patients who were "at risk" of becoming an incident anemia case. | 6 years at maximum |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline characteristics associated with anemia occurrence in unreferred CKD stage 3-5 patients | The prevalence of different baseline characteristics of interest will be summarized. | On Day 1 |
| Comorbidities associated with anemia occurrence in unreferred CKD stage 3-5 patients |
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Inclusion Criteria:
Exclusion Criteria:
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The primary data source will be the Stockholm CREAtinine Measurement (SCREAM) cohort. This is a cohort comprising Swedish citizens residing in or accessing healthcare in Stockholm county with a valid personal identification number and a creatinine measurement taken between 2006 - 2018. Records of patients meeting inclusion criteria, in this healthcare utilization cohort will be linked to national Swedish registries including the Regional healthcare utilization registry, the national Patient Registry and the National Prescribed Drugs Registry.
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Europe Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SE46001 | Stockholm | Sweden |
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| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website. | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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The prevalence of different comorbidities of interest will be summarized. |
| On Day 1 |
| Proportion of patients who initiated anemia treatment after incident of anemia | Anemia treatment initiated within 6 months after development of anemia can include oral iron, IV iron, or erythropoietin-simulating agent (ESA). | 6 months |
| Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia exposed period | MACE will be defined as all-cause mortality, non-fatal stroke and non-fatal myocardial infarction. Anemia exposed period is from incident anemia until event or end of follow-up. | 7 years at maximum |
| Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia non-exposed period | MACE will be defined as all-cause mortality, non-fatal stroke and non-fatal myocardial infarction. The non-exposed period is from baseline (no anemia) until event or the time of anemia development. | 7 years at maximum |
| Correlation of incident anemia and the risk of MACE+ in patients in anemia exposed period | MACE+ will be defined as any record defining MACE, plus hospitalization for unstable angina or hospitalization for congestive heart failure. Anemia exposed period is from incident anemia until event or end of follow-up. | 7 years at maximum |
| Correlation of incident anemia and the risk of MACE+ in patients in non-anemia exposed period | MACE+ will be defined as any record defining MACE, plus hospitalization for unstable angina or hospitalization for congestive heart failure. The non-exposed period is from baseline (no anemia) until event or the time of anemia development. | 7 years at maximum |
| Correlation of incident anemia and the risk of death in patients with anemia | Proportion of death in patients with anemia | 7 years at maximum |
| 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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