Clinical trial NCT05015998: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease
SCREAM database
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 45637
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence rate of anemia in adults with non-dialysis dependent CKD stage 3-5 in primary care
timeFrame: 6 years at maximum
Secondary outcomes:
measure: Baseline characteristics associated with anemia occurrence in unreferred CKD stage 3-5 patients
timeFrame: On Day 1
measure: Comorbidities associated with anemia occurrence in unreferred CKD stage 3-5 patients
timeFrame: On Day 1
measure: Proportion of patients who initiated anemia treatment after incident of anemia
timeFrame: 6 months
measure: Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia exposed period
timeFrame: 7 years at maximum
measure: Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia non-exposed period
timeFrame: 7 years at maximum
measure: Correlation of incident anemia and the risk of MACE+ in patients in anemia exposed period
timeFrame: 7 years at maximum
measure: Correlation of incident anemia and the risk of MACE+ in patients in non-anemia exposed period
timeFrame: 7 years at maximum
measure: Correlation of incident anemia and the risk of death in patients with anemia
timeFrame: 7 years at maximum
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: SE46001
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Central Contact
role: STUDY_DIRECTOR
References: