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

October 29, 2024 updated by: Astellas Pharma a/s

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14415

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • SE46001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Prevalent population of CKD patients > 18 years in the Swedish Renal Registry in 2015 both dependent on dialysis (DD) and not on dialysis (ND); the main analyses will be conducted on patients receiving treatment for renal anaemia.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Non-Interventional
Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs
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.
Other: Non-Interventional
Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.
1 year (data from 2015)
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.
1 year (data from 2015)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
The proportion of ND patients on low, normal and high dose ESA will be calculated.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
ESA use in DD patients
Time Frame: 1 year (data from 2015)
The number of DD patients using/not using ESA.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
4 years (CV events may be compared from data covering 2012 to 2016)
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.
4 years (CV events may be compared from data covering 2012 to 2016)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
All cause mortality: ND
Time Frame: 1 year (data from 2015)
The number of deaths in the ND population.
1 year (data from 2015)
All cause mortality: DD
Time Frame: 1 year (data from 2015)
The number of deaths in the DD population.
1 year (data from 2015)
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).
1 year (data from 2015)
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).
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)
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.
1 year (data from 2015)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma a/s

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Medical Advisor, Astellas Pharma a/s

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1517-MA-3139-SN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Chronic Kidney Disease Associated Anemia

Clinical Trials on Non-Interventional

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings