- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03643601
A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease (ASK)
A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease (ASK)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Stockholm, Sweden
- SE46001
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Non-Dialysis (ND) Patients
For the ND patients, data are captured on each clinic visit during the course of the year (2-4 times per year), the last available record for 2015 will be used.
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Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs
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Dialysis (DD) Patients
For the DD patients, data are input from a randomly selected visit to the hospital in September to October 2015; the evaluation will be based on this record.
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Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iron use in erythropoiesis stimulating agent (ESA) treated patients in the prevalent non-dialysis dependent (ND) population
Time Frame: 1 year (data from 2015)
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Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.
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1 year (data from 2015)
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Iron use in ESA treated patients in the prevalent dialysis dependent (DD) population
Time Frame: 1 year (data from 2015)
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Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.
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1 year (data from 2015)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of non-dialysis dependent (ND) patients on low, normal, high dose erythropoiesis stimulating agent (ESA)
Time Frame: 1 year (data from 2015)
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The proportion of ND patients on low, normal and high dose ESA will be calculated.
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1 year (data from 2015)
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Proportion of dialysis dependent (DD) patients on low, normal, high dose ESA
Time Frame: 1 year (data from 2015)
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The proportion of DD patients on low, normal and high dose ESA will be calculated.
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1 year (data from 2015)
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ESA use in ND patients at each CKD stage
Time Frame: 1 year (data from 2015)
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The number of ND patients using/not using ESA at each CKD stage.
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1 year (data from 2015)
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ESA use in DD patients
Time Frame: 1 year (data from 2015)
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The number of DD patients using/not using ESA.
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1 year (data from 2015)
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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)
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Proportion of ND patients treated with ESAs in each CKD stage with or without oral/iv iron.
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1 year (data from 2015)
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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)
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Proportion of DD patients treated with ESAs in each CKD stage with or without oral/iv iron.
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1 year (data from 2015)
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Proportion of ESA treated ND patients within Haemoglobin (Hb) levels within pre-specified target range
Time Frame: 1 year (data from 2015)
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Proportion of ND patients within pre-specified Hb target.
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1 year (data from 2015)
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Proportion of ESA treated DD patients within Haemoglobin (Hb) levels within pre-specified target range
Time Frame: 1 year (data from 2015)
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Proportion of DD patients within pre-specified Hb target.
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1 year (data from 2015)
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Proportion of ND patients with anemia who are not treated with ESAs
Time Frame: 1 year (data from 2015)
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Proportion of ND patients with anemia not treated with ESAs.
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1 year (data from 2015)
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Proportion of DD patients with anemia who are not treated with ESAs
Time Frame: 1 year (data from 2015)
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Proportion of DD patients with anemia not treated with ESAs.
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1 year (data from 2015)
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Proportion of ESA treated ND patients with low or medium and high C-reactive protein (CRP)
Time Frame: 1 year (data from 2015)
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Proportion of ND patients with low, medium or high CRP.
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1 year (data from 2015)
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Proportion of ESA treated DD patients with low or medium and high CRP
Time Frame: 1 year (data from 2015)
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Proportion of DD patients with low, medium or high CRP.
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1 year (data from 2015)
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Proportion of ESA treated ND patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations
Time Frame: 1 year (data from 2015)
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Proportion of ESA treated ND patients with hyperlipidemia High density lipoprotein / Low density lipoprotein (HDL/LDL) and/or taking lipid lowering drugs.
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1 year (data from 2015)
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Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations
Time Frame: 1 year (data from 2015)
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Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering drugs.
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1 year (data from 2015)
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Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive medication
Time Frame: 1 year (data from 2015)
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Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive drugs.
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1 year (data from 2015)
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Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive medication
Time Frame: 1 year (data from 2015)
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Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive drugs.
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1 year (data from 2015)
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Number of ND patients with serious cardiovascular events
Time Frame: 4 years (CV events may be compared from data covering 2012 to 2016)
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The number of ND patients with serious cardiovascular events (i.e., myocardial infarction, heart failure, myocardial ischemia) will be evaluated.
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4 years (CV events may be compared from data covering 2012 to 2016)
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Number of DD patients with serious cardiovascular events
Time Frame: 4 years (CV events may be compared from data covering 2012 to 2016)
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The number of DD patients with serious cardiovascular events (i.e., myocardial infarction, heart failure, myocardial ischemia) will be evaluated.
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4 years (CV events may be compared from data covering 2012 to 2016)
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Number of ND patients with serious thromboembolic events
Time Frame: 1 year (data from 2015)
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The number of ND patients with serious thromboembolic events (i.e.
stroke) will be evaluated.
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1 year (data from 2015)
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Number of DD patients with serious thromboembolic events
Time Frame: 1 year (data from 2015)
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The number of DD patients with serious thromboembolic events (i.e.
stroke) will be evaluated.
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1 year (data from 2015)
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All cause mortality: ND
Time Frame: 1 year (data from 2015)
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The number of deaths in the ND population.
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1 year (data from 2015)
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All cause mortality: DD
Time Frame: 1 year (data from 2015)
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The number of deaths in the DD population.
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1 year (data from 2015)
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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)
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Scatter plots of ESA dose against hemoglobin level for CKD severity (stage 3, 4, 5 and DD).
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1 year (data from 2015)
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Correlation between Haemoglobin (Hb) level and CKD severity: ND
Time Frame: 1 year (data from 2015)
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Box plots of ESA dose against CKD severity (stage 3,4, 5).
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1 year (data from 2015)
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Correlation between ESA dose and C-reactive protein (CRP) level: ND
Time Frame: 1 year (data from 2015)
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Scatter plot of ESA dose versus CRP level in ND population.
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1 year (data from 2015)
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Correlation between ESA dose and CRP level: DD
Time Frame: 1 year (data from 2015)
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Scatter plot of ESA dose versus CRP level in DD population.
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1 year (data from 2015)
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Relationship between ESA dose and occurrence of Cardiovascular (CV) events in ND population
Time Frame: 1 year (data from 2015)
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Box plot of ESA dose in ND patients with or without CV events.
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1 year (data from 2015)
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Relationship between Hb level and occurrence of CV events in ND population
Time Frame: 1 year (data from 2015)
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Box plot of Hb level in ND patients with or without CV events.
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1 year (data from 2015)
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Relationship between Hb level and occurrence of CV events in DD population
Time Frame: 1 year (data from 2015)
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Box plot of Hb level in DD patients with or without CV events.
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1 year (data from 2015)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Medical Advisor, Astellas Pharma a/s
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1517-MA-3139-SN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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