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

NCT05015998 | Completed

• 1 other identifier: 1517-MA-1569
• Study Type: observational
• Target: 45,637
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease; SCREAM database

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Baseline characteristics associated with anemia occurrence in unreferred CKD stage 3-5 patients

  On Day 1

• Comorbidities associated with anemia occurrence in unreferred CKD stage 3-5 patients

  On Day 1

• Proportion of patients who initiated anemia treatment after incident of anemia

  6 months

• Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia exposed period

  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

  7 years at maximum

Study Arms (1)

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

Interventions

Non-interventional OTHER

Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs

Non-dialysis dependent patients with CKD stage 3-5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (1)

SE46001

Stockholm, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Central Contact

  Astellas Pharma Europe Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 23, 2021
• Study Start: November 30, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)