Chronic Kidney Disease Associated AnemiaASKNCT03643601
A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Disease Associated Anemia, run by Astellas Pharma a/s at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Associated Anemia
- What is being tested?
- Non-Interventional
- How many people
- 14,415 participants
- Where
- 1 siteSweden
- Study dates
- 24 Sep 2018to 4 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Kidney Disease Associated Anemia
- Being tested
- Non-Interventional
- Keywords
- erythropoiesis stimulating agent, chronic kidney disease associated anemia, ASP1517
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional | |
| 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. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron use in erythropoiesis stimulating agent (ESA) treated patients in the prevalent non-dialysis dependent (ND) population
Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.
Measured: 1 year (data from 2015)
Iron use in ESA treated patients in the prevalent dialysis dependent (DD) population
Route of administration of iron (oral, intravenous (IV), or no iron use) over the source period.
Measured: 1 year (data from 2015)
Secondary outcomes (29)
Proportion of non-dialysis dependent (ND) patients on low, normal, high dose erythropoiesis stimulating agent (ESA)
The proportion of ND patients on low, normal and high dose ESA will be calculated.
Measured: 1 year (data from 2015)
Proportion of dialysis dependent (DD) patients on low, normal, high dose ESA
The proportion of DD patients on low, normal and high dose ESA will be calculated.
Measured: 1 year (data from 2015)
ESA use in ND patients at each CKD stage
The number of ND patients using/not using ESA at each CKD stage.
Measured: 1 year (data from 2015)
ESA use in DD patients
The number of DD patients using/not using ESA.
Measured: 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
Proportion of ND patients treated with ESAs in each CKD stage with or without oral/iv iron.
Measured: 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
Proportion of DD patients treated with ESAs in each CKD stage with or without oral/iv iron.
Measured: 1 year (data from 2015)
Proportion of ESA treated ND patients within Haemoglobin (Hb) levels within pre-specified target range
Proportion of ND patients within pre-specified Hb target.
Measured: 1 year (data from 2015)
Proportion of ESA treated DD patients within Haemoglobin (Hb) levels within pre-specified target range
Proportion of DD patients within pre-specified Hb target.
Measured: 1 year (data from 2015)
Proportion of ND patients with anemia who are not treated with ESAs
Proportion of ND patients with anemia not treated with ESAs.
Measured: 1 year (data from 2015)
Proportion of DD patients with anemia who are not treated with ESAs
Proportion of DD patients with anemia not treated with ESAs.
Measured: 1 year (data from 2015)
Proportion of ESA treated ND patients with low or medium and high C-reactive protein (CRP)
Proportion of ND patients with low, medium or high CRP.
Measured: 1 year (data from 2015)
Proportion of ESA treated DD patients with low or medium and high CRP
Proportion of DD patients with low, medium or high CRP.
Measured: 1 year (data from 2015)
Proportion of ESA treated ND patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations
Proportion of ESA treated ND patients with hyperlipidemia High density lipoprotein / Low density lipoprotein (HDL/LDL) and/or taking lipid lowering drugs.
Measured: 1 year (data from 2015)
Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering preparations
Proportion of ESA treated DD patients with hyperlipidemia (HDL/LDL) and/or taking lipid lowering drugs.
Measured: 1 year (data from 2015)
Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive medication
Proportion of ESA treated ND patients with high blood pressure and/or taking anti-hypertensive drugs.
Measured: 1 year (data from 2015)
Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive medication
Proportion of ESA treated DD patients with high blood pressure and/or taking anti-hypertensive drugs.
Measured: 1 year (data from 2015)
Number of ND patients with serious cardiovascular events
The number of ND patients with serious cardiovascular events (i.e., myocardial infarction, heart failure, myocardial ischemia) will be evaluated.
Measured: 4 years (CV events may be compared from data covering 2012 to 2016)
Number of DD patients with serious cardiovascular events
The number of DD patients with serious cardiovascular events (i.e., myocardial infarction, heart failure, myocardial ischemia) will be evaluated.
Measured: 4 years (CV events may be compared from data covering 2012 to 2016)
Number of ND patients with serious thromboembolic events
The number of ND patients with serious thromboembolic events (i.e. stroke) will be evaluated.
Measured: 1 year (data from 2015)
Number of DD patients with serious thromboembolic events
The number of DD patients with serious thromboembolic events (i.e. stroke) will be evaluated.
Measured: 1 year (data from 2015)
All cause mortality: ND
The number of deaths in the ND population.
Measured: 1 year (data from 2015)
All cause mortality: DD
The number of deaths in the DD population.
Measured: 1 year (data from 2015)
Correlation between ESA dose and Hb level in relation to CKD severity (stage 3,4, 5 and DD)
Scatter plots of ESA dose against hemoglobin level for CKD severity (stage 3, 4, 5 and DD).
Measured: 1 year (data from 2015)
Correlation between Haemoglobin (Hb) level and CKD severity: ND
Box plots of ESA dose against CKD severity (stage 3,4, 5).
Measured: 1 year (data from 2015)
Correlation between ESA dose and C-reactive protein (CRP) level: ND
Scatter plot of ESA dose versus CRP level in ND population.
Measured: 1 year (data from 2015)
Correlation between ESA dose and CRP level: DD
Scatter plot of ESA dose versus CRP level in DD population.
Measured: 1 year (data from 2015)
Relationship between ESA dose and occurrence of Cardiovascular (CV) events in ND population
Box plot of ESA dose in ND patients with or without CV events.
Measured: 1 year (data from 2015)
Relationship between Hb level and occurrence of CV events in ND population
Box plot of Hb level in ND patients with or without CV events.
Measured: 1 year (data from 2015)
Relationship between Hb level and occurrence of CV events in DD population
Box plot of Hb level in DD patients with or without CV events.
Measured: 1 year (data from 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start24 Sep 2018
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Associated AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14,415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma a/s
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Advisor, Study chair, Astellas Pharma a/s
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643601
- Sponsor's protocol ID
- 1517-MA-3139-SN
- Acronym
- ASK
- Status last verified
- Oct 2024
- First submitted
- 21 Aug 2018
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease (ASK)
- ClinicalTrials.gov ID
- NCT03643601
- Acronym / sponsor ID
- ASK / 1517-MA-3139-SN
- Conditions
- Chronic Kidney Disease Associated Anemia
- Keywords
- erythropoiesis stimulating agent, chronic kidney disease associated anemia, ASP1517
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,415 participants (actual)
- Lead sponsor
- Astellas Pharma a/sIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Dialysis (ND) Patients | – | Other: Non-InterventionalFor 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. |
| Dialysis (DD) Patients | – | Other: Non-InterventionalFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- For ND-CKD population:
- For DD-CKD population
Key exclusion criteria (1 listed)
- not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalEpidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs | Other | Dialysis (DD) Patients, Non-Dialysis (ND) Patients |
Primary outcome
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.
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.
29 secondary outcomes
Proportion of non-dialysis dependent (ND) patients on low, normal, high dose erythropoiesis stimulating agent (ESA)
Time frame: 1 year (data from 2015)
Proportion of dialysis dependent (DD) patients on low, normal, high dose ESA
Time frame: 1 year (data from 2015)
ESA use in ND patients at each CKD stage
Time frame: 1 year (data from 2015)
ESA use in DD patients
Time frame: 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 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 ESA treated ND patients within Haemoglobin (Hb) levels within pre-specified target range
Time frame: 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 ND patients with anemia who are not treated with ESAs
Time frame: 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 ESA treated ND patients with low or medium and high C-reactive protein (CRP)
Time frame: 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 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 DD 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 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 medication
Time frame: 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)
Number of DD patients with serious cardiovascular events
Time frame: 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)
Number of DD patients with serious thromboembolic events
Time frame: 1 year (data from 2015)
All cause mortality: ND
Time frame: 1 year (data from 2015)
All cause mortality: DD
Time frame: 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)
Correlation between Haemoglobin (Hb) level and CKD severity: ND
Time frame: 1 year (data from 2015)
Correlation between ESA dose and C-reactive protein (CRP) level: ND
Time frame: 1 year (data from 2015)
Correlation between ESA dose and CRP level: DD
Time frame: 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)
Relationship between Hb level and occurrence of CV events in ND population
Time frame: 1 year (data from 2015)
Relationship between Hb level and occurrence of CV events in DD population
Time frame: 1 year (data from 2015)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Advisor study chair
Astellas Pharma a/s
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Associated Anemia, run by Astellas Pharma a/s at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron use in erythropoiesis stimulating agent (ESA) treated patients in the prevalent non-dialysis dependent (ND) population (time frame: 1 year (data from 2015)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.