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NCT Number: 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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SE46001

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional

Other

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

Primary outcomes

  1. Incidence rate of anemia in adults with non-dialysis dependent CKD stage 3-5 in primary care

    Time frame: 6 years at maximum

    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.

Secondary outcomes

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

    Time frame: On Day 1

    The prevalence of different baseline characteristics of interest will be summarized.

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

    Time frame: On Day 1

    The prevalence of different comorbidities of interest will be summarized.

  3. Proportion of patients who initiated anemia treatment after incident of anemia

    Time frame: 6 months

    Anemia treatment initiated within 6 months after development of anemia can include oral iron, IV iron, or erythropoietin-simulating agent (ESA).

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

    Time frame: 7 years at maximum

    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.

  5. Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia non-exposed period

    Time frame: 7 years at maximum

    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.

  6. Correlation of incident anemia and the risk of MACE+ in patients in anemia exposed period

    Time frame: 7 years at maximum

    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. Correlation of incident anemia and the risk of MACE+ in patients in non-anemia exposed period

    Time frame: 7 years at maximum

    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.

  8. Correlation of incident anemia and the risk of death in patients with anemia

    Time frame: 7 years at maximum

    Proportion of death in patients with anemia

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2021
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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