Chronic Kidney DiseasesSCREAMNCT06239129
The Stockholm CREAtinine Measurements Project
An observational study of Chronic Kidney Diseases and Acute Kidney Injury, run by Karolinska Institutet.
Trial summary
The Stockholm CREAtinine Measurements (SCREAM) project is a healthcare utilization cohort including, at present, all adult residents in Stockholm between 2006 and 2021. The region of Stockholm had a population of 2.3 million citizens in 2021and provides universal healthcare with a single unified health-system. Read more about this study
- Who is it for?
- Ages 0 to 110 years
- Conditions the study is for
- Chronic Kidney Diseases, Acute Kidney Injury, Diabetes Mellitus
- What is being tested?
- Initiation of specific medications, Undertaking of specific procedures and Abnormalities in specific laboratory tests
- Type of treatment
- Surgery or procedure
- How many people
- 3,200,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2022
- How long will I take part?
- 15 Years
- 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 0 to 110 years
- All sexes
- Child, Adult, Older adult
Study population: Stockholm residents with/without ever testing for creatinine or albumuninuria
Who may be able to join
- For both cohorts:
- Be a resident of Stockholm during 2006-2021, of all ages
- For the primary cohort:
- To have undertaken at least one test of serum creatinine or albuminuria during 2006-2021. If this condition is met, we will then extract a broad range of laboratory tests
- For the secondary cohort:
- Anyone not undertaking a test of serum creatinine or albuminuria will conform the secondary cohort. In this cohort we will not extract any other laboratory test, but will obtain the rest of healthcare information
Who cannot join
- None
About this study
Official title: The Stockholm CREAtinine Measurements (SCREAM) Project
The Stockholm CREAtinine Measurements (SCREAM) project is a healthcare utilization cohort including, at present, all adult residents in Stockholm between 2006 and 2021. The region of Stockholm had a population of 2.3 million citizens in 2021and provides universal healthcare with a single unified health-system. Administrative databases with complete information on socidemographic data, healthcare use, diagnoses and therapeutic/surgical procedures, and vital status were enriched with performed laboratory tests, dispensed prescriptions at Swedish pharmacies and validated kidney replacement therapy endpoints. Registries were linked and de-identified by the Swedish National Board of Welfare and are considered to have no or minimal loss to follow-up. Because the study utilized de-identified data, it was deemed not to require informed consent and was approved by the regional ethical review boards and the Swedish National Board of Welfare.
For detailed description of available data and linked registers please consult:
https://pubmed.ncbi.nlm.nih.gov/35028991/
Read the detailed description
Please consult cohort description in:
https://pubmed.ncbi.nlm.nih.gov/35028991/ https://pubmed.ncbi.nlm.nih.gov/26798472/
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury, Diabetes Mellitus, Cardiovascular Diseases, Hypertension
- Being tested
- Initiation of specific medications, Undertaking of specific procedures, Abnormalities in specific laboratory tests
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury, Diabetes Mellitus, Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiation of specific medicationsDrug
Also called multiple therapies studied within this database
multiple therapies studied within this database
Undertaking of specific proceduresProcedure or surgery
multiple procedures/surgeries studied within this database
Abnormalities in specific laboratory testsDiagnostic test
multiple abnormalities in laboratory values (i.e. CRP, cholesterol, eGFR, potassium) studied within this database
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse health events by levels of kidney function
multiple outcomes evaluated such as cardiovascular events, fractures, dementia, cancer, etc, all of them based on claims data and/or laboratory data
Measured: 2006-2021
Safety and efficacy of medications by levels of kidney function
multiple outcomes evaluated depending on the treatments of interest, all of them based on claims data and/or laboratory data
Measured: 2006-2021
Effect of medications or conditions on kidney function decline
Evaluation of changes in kidney function over time upon occurrence of a certain condition (i.e., heart failure or covid19 infection) or initiation of a specific medication
Measured: 2006-2021
Secondary outcomes (1)
Adverse health events associated to laboratory abnormalities
Same as primary objectives but for other laboratory abnormalities different from kidney function measures
Measured: 2006-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Jan 2006
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 3,200,000 participants (actual)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Juan Jesus Carrero, Karolinska Institutet
- Investigators
- Juan J Carrero, Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239129
- Sponsor's protocol ID
- 000001
- Acronym
- SCREAM
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Possibility to share data for collaborative academic research purposes that comply with institutional, national and international ethic principles and legislation on data sharing, access and investigation
Publications
Russel WA, Fu EL, Bosi A, Caldinelli A, Inker LA, Chang AR, Levey AS, Carrero JJ. Obesity, Underweight, and Accuracy of eGFR Using Cystatin C and Creatinine in a Northern European Population. J Am Soc Nephrol. 2025 Nov 1;36(11):2177-2189. doi: 10.1681/ASN.0000000760. Epub 2025 Jun 13.
PubMed 40512561
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stockholm CREAtinine Measurements (SCREAM) Project
- ClinicalTrials.gov ID
- NCT06239129
- Acronym / sponsor ID
- SCREAM / 000001
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury, Diabetes Mellitus, Cardiovascular Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,200,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Feb 2024 (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 Stockholm CREAtinine Measurements (SCREAM) project is a healthcare utilization cohort including, at present, all adult residents in Stockholm between 2006 and 2021. The region of Stockholm had a population of 2.3 million citizens in 2021and provides universal healthcare with a single unified health-system. Administrative databases with complete information on socidemographic data, healthcare use, diagnoses and therapeutic/surgical procedures, and vital status were enriched with performed laboratory tests, dispensed prescriptions at Swedish pharmacies and validated kidney replacement therapy endpoints. Registries were linked and de-identified by the Swedish National Board of Welfare and are considered to have no or minimal loss to follow-up. Because the study utilized de-identified data, it was deemed not to require informed consent and was approved by the regional ethical review boards and the Swedish National Board of Welfare.
For detailed description of available data and linked registers please consult:
https://pubmed.ncbi.nlm.nih.gov/35028991/
Detailed description
Please consult cohort description in:
https://pubmed.ncbi.nlm.nih.gov/35028991/ https://pubmed.ncbi.nlm.nih.gov/26798472/
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 0 to 110 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Stockholm residents with/without ever testing for creatinine or albumuninuria
Key inclusion criteria (6 listed)
- Be a resident of Stockholm during 2006-2021, of all ages
- To have undertaken at least one test of serum creatinine or albuminuria during 2006-2021. If this condition is met, we will then extract a broad range of laboratory tests
- Anyone not undertaking a test of serum creatinine or albuminuria will conform the secondary cohort. In this cohort we will not extract any other laboratory test, but will obtain the rest of healthcare information
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Initiation of specific medicationsAlso: multiple therapies studied within this databasemultiple therapies studied within this database | Drug | – |
| Undertaking of specific proceduresmultiple procedures/surgeries studied within this database | Procedure or surgery | – |
| Abnormalities in specific laboratory testsmultiple abnormalities in laboratory values (i.e. CRP, cholesterol, eGFR, potassium) studied within this database | Diagnostic test | – |
Primary outcome
Adverse health events by levels of kidney function
Time frame: 2006-2021
multiple outcomes evaluated such as cardiovascular events, fractures, dementia, cancer, etc, all of them based on claims data and/or laboratory data
Safety and efficacy of medications by levels of kidney function
Time frame: 2006-2021
multiple outcomes evaluated depending on the treatments of interest, all of them based on claims data and/or laboratory data
Effect of medications or conditions on kidney function decline
Time frame: 2006-2021
Evaluation of changes in kidney function over time upon occurrence of a certain condition (i.e., heart failure or covid19 infection) or initiation of a specific medication
1 secondary outcome
Adverse health events associated to laboratory abnormalities
Time frame: 2006-2021
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 2 Feb 2024.
- Derived from this study: PubMed 40512561Russel WA, Fu EL, Bosi A, Caldinelli A, Inker LA, Chang AR, Levey AS, Carrero JJ. Obesity, Underweight, and Accuracy of eGFR Using Cystatin C and Creatinine in a Northern European Population. J Am Soc Nephrol. 2025 Nov 1;36(11):2177-2189. doi: 10.1681/ASN.0000000760. Epub 2025 Jun 13.
- Individual participant dataSharing planned: Yes. Possibility to share data for collaborative academic research purposes that comply with institutional, national and international ethic principles and legislation on data sharing, access and investigation
Related trials for Chronic Kidney Diseases
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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.
Juan J Carrero, Prof principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Acute Kidney Injury, run by Karolinska Institutet.
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 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Adverse health events by levels of kidney function (time frame: 2006-2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06239129, which also lists 1 linked publication.
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 2 Feb 2024.