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Completed

NCT Number: NCT03643601

A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease

The primary purpose of this study is to describe renal anemia treatment patterns in non-dialysis dependent (ND) and dialysis dependent (DD) populations, with a particular focus on iron use in erythropoiesis stimulating agent (ESA) treated patients.

This study will also provide an epidemiological description of chronic kidney disease (CKD) associated anemia in relation to CKD stage, dialysis modality and underlying morbidity, as well as describe the relationship between inflammation and ESA treatment and describe the associated cardiovascular illness in ESA treated patients.

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Key information

Conditions

Chronic Kidney Disease Associated Anemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SE46001

Stockholm, Sweden

About this study

Data from year 2015 will be used for the prevalence analysis.The prevalent population of CKD patients > 18 years in the Swedish Renal Registry in 2015 both dependent on dialysis (DD) and not on dialysis (ND).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • For ND-CKD population:
  • all prevalent patients with a CKD with Estimated Glomerular filtration rate (eGFR) < 45ml/min/1.73m2 with a recorded visit pre-dialysis in Swedish Renal Registry (SRR) in 2015
  • Not on dialysis
  • For DD-CKD population
  • All prevalent patients taking part in the yearly cross-sectional dialysis investigation in SRR in 2015
  • Dialysis dependent

Exclusion criteria

  • not applicable

Treatment and study plan

Non-Interventional

Other

Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs

Primary outcomes

  1. Iron use in erythropoiesis stimulating agent (ESA) treated patients in the prevalent non-dialysis dependent (ND) population

    Time frame: 1 year (data from 2015)

    Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.

  2. Iron use in ESA treated patients in the prevalent dialysis dependent (DD) population

    Time frame: 1 year (data from 2015)

    Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.

Secondary outcomes

  1. Proportion of non-dialysis dependent (ND) patients on low, normal, high dose erythropoiesis stimulating agent (ESA)

    Time frame: 1 year (data from 2015)

    The proportion of ND patients on low, normal and high dose ESA will be calculated.

  2. Proportion of dialysis dependent (DD) patients on low, normal, high dose ESA

    Time frame: 1 year (data from 2015)

    The proportion of DD patients on low, normal and high dose ESA will be calculated.

  3. ESA use in ND patients at each CKD stage

    Time frame: 1 year (data from 2015)

    The number of ND patients using/not using ESA at each CKD stage.

  4. ESA use in DD patients

    Time frame: 1 year (data from 2015)

    The number of DD patients using/not using ESA.

  5. Proportion of ND patients treated with ESAs at each chronic kidney disease (CKD) stage with or without oral/IV iron

    Time frame: 1 year (data from 2015)

    Proportion of ND patients treated with ESAs in each CKD stage with or without oral/iv iron.

  6. Proportion of DD patients treated with ESAs at each chronic kidney disease (CKD) stage with or without oral/IV iron

    Time frame: 1 year (data from 2015)

    Proportion of DD patients treated with ESAs in each CKD stage with or without oral/iv iron.

  7. Proportion of ESA treated ND patients within Haemoglobin (Hb) levels within pre-specified target range

    Time frame: 1 year (data from 2015)

    Proportion of ND patients within pre-specified Hb target.

  8. Proportion of ESA treated DD patients within Haemoglobin (Hb) levels within pre-specified target range

    Time frame: 1 year (data from 2015)

    Proportion of DD patients within pre-specified Hb target.

  9. Proportion of ND patients with anemia who are not treated with ESAs

    Time frame: 1 year (data from 2015)

    Proportion of ND patients with anemia not treated with ESAs.

  10. Proportion of DD patients with anemia who are not treated with ESAs

    Time frame: 1 year (data from 2015)

    Proportion of DD patients with anemia not treated with ESAs.

  11. Proportion of ESA treated ND patients with low or medium and high C-reactive protein (CRP)

    Time frame: 1 year (data from 2015)

    Proportion of ND patients with low, medium or high CRP.

  12. Proportion of ESA treated DD patients with low or medium and high CRP

    Time frame: 1 year (data from 2015)

    Proportion of DD patients with low, medium or high CRP.

  13. Proportion of ESA treated ND patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations

    Time frame: 1 year (data from 2015)

    Proportion of ESA treated ND patients with hyperlipidemia High density lipoprotein / Low density lipoprotein (HDL/LDL) and/or taking lipid lowering drugs.

  14. Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations

    Time frame: 1 year (data from 2015)

    Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering drugs.

  15. Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive medication

    Time frame: 1 year (data from 2015)

    Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive drugs.

  16. Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive medication

    Time frame: 1 year (data from 2015)

    Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive drugs.

  17. Number of ND patients with serious cardiovascular events

    Time frame: 4 years (CV events may be compared from data covering 2012 to 2016)

    The number of ND patients with serious cardiovascular events (i.e., myocardial infarction, heart failure, myocardial ischemia) will be evaluated.

  18. Number of DD patients with serious cardiovascular events

    Time frame: 4 years (CV events may be compared from data covering 2012 to 2016)

    The number of DD patients with serious cardiovascular events (i.e., myocardial infarction, heart failure, myocardial ischemia) will be evaluated.

  19. Number of ND patients with serious thromboembolic events

    Time frame: 1 year (data from 2015)

    The number of ND patients with serious thromboembolic events (i.e. stroke) will be evaluated.

  20. Number of DD patients with serious thromboembolic events

    Time frame: 1 year (data from 2015)

    The number of DD patients with serious thromboembolic events (i.e. stroke) will be evaluated.

  21. All cause mortality: ND

    Time frame: 1 year (data from 2015)

    The number of deaths in the ND population.

  22. All cause mortality: DD

    Time frame: 1 year (data from 2015)

    The number of deaths in the DD population.

  23. Correlation between ESA dose and Hb level in relation to CKD severity (stage 3,4, 5 and DD)

    Time frame: 1 year (data from 2015)

    Scatter plots of ESA dose against hemoglobin level for CKD severity (stage 3, 4, 5 and DD).

  24. Correlation between Haemoglobin (Hb) level and CKD severity: ND

    Time frame: 1 year (data from 2015)

    Box plots of ESA dose against CKD severity (stage 3,4, 5).

  25. Correlation between ESA dose and C-reactive protein (CRP) level: ND

    Time frame: 1 year (data from 2015)

    Scatter plot of ESA dose versus CRP level in ND population.

  26. Correlation between ESA dose and CRP level: DD

    Time frame: 1 year (data from 2015)

    Scatter plot of ESA dose versus CRP level in DD population.

  27. Relationship between ESA dose and occurrence of Cardiovascular (CV) events in ND population

    Time frame: 1 year (data from 2015)

    Box plot of ESA dose in ND patients with or without CV events.

  28. Relationship between Hb level and occurrence of CV events in ND population

    Time frame: 1 year (data from 2015)

    Box plot of Hb level in ND patients with or without CV events.

  29. Relationship between Hb level and occurrence of CV events in DD population

    Time frame: 1 year (data from 2015)

    Box plot of Hb level in DD patients with or without CV events.

Sponsors and collaborators

Lead sponsor

Astellas Pharma a/s

Industry

Registry information

Official study title

A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease (ASK)

Acronym: ASK

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2018
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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