An observational study in Chronic Kidney Disease, sponsored by Astellas Pharma Europe Ltd.. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Astellas Pharma Europe Ltd. (part of Astellas Pharma Inc) · Observational
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.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 45,637 is above the median of 200 across 889 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Astellas Pharma Europe Ltd. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
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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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Exclusion Criteria:
A cohort of patients will be created from the Stockholm CREAtinine Measurement (SCREAM) cohort based on the eligibility criteria.
Other: Non-interventional
Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs
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.
Time frame: 6 years at maximum
Baseline characteristics associated with anemia occurrence in unreferred CKD stage 3-5 patients
The prevalence of different baseline characteristics of interest will be summarized.
Time frame: On Day 1
Comorbidities associated with anemia occurrence in unreferred CKD stage 3-5 patients
The prevalence of different comorbidities of interest will be summarized.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 years at maximum
Correlation of incident anemia and the risk of death in patients with anemia
Proportion of death in patients with anemia
Time frame: 7 years at maximum
Plan to share: No — 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/.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →