Chronic Kidney DiseaseNCT05015998
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
An observational study of Chronic Kidney Disease, run by Astellas Pharma Europe Ltd. at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Non-interventional
- How many people
- 45,637 participants
- Where
- 1 siteSweden
- Study dates
- 30 Nov 2021to 30 Nov 2021
- 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: The primary data source will be the Stockholm CREAtinine Measurement (SCREAM) cohort. This is a cohort comprising Swedish citizens residing in or accessing healthcare in Stockholm county with a valid personal identification number and a creatinine measurement taken between 2006 - 2018. Records of patients meeting inclusion criteria, in this healthcare utilization cohort will be linked to national Swedish registries including the Regional healthcare utilization registry, the national Patient Registry and the National Prescribed Drugs Registry.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Non-interventional
- Keywords
- Chronic kidney disease, SCREAM database
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs
| Study group | Role | What they receive |
|---|---|---|
| Non-dialysis dependent patients with CKD stage 3-5 | A cohort of patients will be created from the Stockholm CREAtinine Measurement (SCREAM) cohort based on the eligibility criteria. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of anemia in adults with non-dialysis dependent CKD stage 3-5 in primary care
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.
Measured: 6 years at maximum
Secondary outcomes (8)
Baseline characteristics associated with anemia occurrence in unreferred CKD stage 3-5 patients
The prevalence of different baseline characteristics of interest will be summarized.
Measured: On Day 1
Comorbidities associated with anemia occurrence in unreferred CKD stage 3-5 patients
The prevalence of different comorbidities of interest will be summarized.
Measured: On Day 1
Proportion of patients who initiated anemia treatment after incident of anemia
Anemia treatment initiated within 6 months after development of anemia can include oral iron, IV iron, or erythropoietin-simulating agent (ESA).
Measured: 6 months
Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia exposed period
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.
Measured: 7 years at maximum
Correlation of incident anemia and the risk of major adverse cardiac events (MACE) events in patients in anemia non-exposed period
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.
Measured: 7 years at maximum
Correlation of incident anemia and the risk of MACE+ in patients in anemia exposed period
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.
Measured: 7 years at maximum
Correlation of incident anemia and the risk of MACE+ in patients in non-anemia exposed period
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.
Measured: 7 years at maximum
Correlation of incident anemia and the risk of death in patients with anemia
Proportion of death in patients with anemia
Measured: 7 years at maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start30 Nov 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- 45,637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015998
- Sponsor's protocol ID
- 1517-MA-1569
- Status last verified
- Oct 2024
- First submitted
- 15 Aug 2021
- 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 Evaluation of the ePidemiology of anEmia Associated With chroNic Kidney Disease in Patients in Primary Care Using The Stockholm CREAtinine Measurement (SCREAM) Register
- ClinicalTrials.gov ID
- NCT05015998
- Acronym / sponsor ID
- 1517-MA-1569
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, SCREAM database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45,637 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 23 Aug 2021 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-dialysis dependent patients with CKD stage 3-5 | – | Other: Non-interventionalA cohort of patients will be created from the Stockholm CREAtinine Measurement (SCREAM) cohort based on the eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary data source will be the Stockholm CREAtinine Measurement (SCREAM) cohort. This is a cohort comprising Swedish citizens residing in or accessing healthcare in Stockholm county with a valid personal identification number and a creatinine measurement taken between 2006 - 2018. Records of patients meeting inclusion criteria, in this healthcare utilization cohort will be linked to national Swedish registries including the Regional healthcare utilization registry, the national Patient Registry and the National Prescribed Drugs Registry.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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-interventionalEpidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs | Other | Non-dialysis dependent patients with CKD stage 3-5 |
Primary outcome
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.
8 secondary outcomes
Baseline characteristics associated with anemia occurrence in unreferred CKD stage 3-5 patients
Time frame: On Day 1
Comorbidities associated with anemia occurrence in unreferred CKD stage 3-5 patients
Time frame: On Day 1
Proportion of patients who initiated anemia treatment after incident of anemia
Time frame: 6 months
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
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
Correlation of incident anemia and the risk of MACE+ in patients in anemia exposed period
Time frame: 7 years at maximum
Correlation of incident anemia and the risk of MACE+ in patients in non-anemia exposed period
Time frame: 7 years at maximum
Correlation of incident anemia and the risk of death in patients with anemia
Time frame: 7 years at maximum
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.
- Link to results on the Astellas Clinical Study Results website.Link provided by the sponsor.
- 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.
Central Contact study director
Astellas Pharma Europe Ltd.
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, run by Astellas Pharma Europe Ltd. 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 3 inclusion and 5 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?
Incidence rate of anemia in adults with non-dialysis dependent CKD stage 3-5 in primary care (time frame: 6 years at maximum). 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.