A Study to Evaluate the ePidemiology of anEmia Associated With chroNic Kidney Disease in Patients in Primary Care Using The Stockholm CREAtinine Measurement (SCREAM) Register

A Non-interventional Evaluation of the ePidemiology of anEmia Associated With chroNic Kidney Disease in Patients in Primary Care Using The Stockholm CREAtinine Measurement (SCREAM) Register

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: Non-interventional

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 45637

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • SE46001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Patient entered in SCREAM between 2012 and 2018
• With two consecutive plasma-creatinine test(s) indicating an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2
• With at least one eligible Hb after eGFR < 60 mL/min/1.73 m^2. The date of the first eligible Hb test is the study entry point/index date of the study.

Exclusion Criteria:

• Patient who has had a recent pregnancy or childbirth (issued diagnosis within 2 years prior to index date).
• Patient with ongoing/recent cancer (diagnosed within the previous 3 years), haematological diseases or leukaemia.
• Patient with chronic infections (hepatitis, tuberculosis, or human immunodeficiency virus [HIV]); note by definition chronic infections are chronic and look back period will be to 1997.
• Patients with anemia at baseline (index date), defined by an anemia diagnosis in the year prior, a baseline Hb value within the anemia range according to the WHO definition, or the presence of a recent dispensation of ESA or iron (up to six months prior).
• Patient referred to nephrologist within the previous 2 years from cohort entry/ index date.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Non-interventional; Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe Ltd.
• Investigators: Study Director: Central Contact, Astellas Pharma Europe Ltd.

Publications and helpful links

Helpful Links

• Link to results on the Astellas Clinical Study Results website.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: August 15, 2021
• First Submitted That Met QC Criteria: August 15, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Chronic kidney disease; SCREAM database
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 1517-MA-1569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No