Chronic Kidney DiseasesSCOPENCT02691546
Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE)
An observational study of Chronic Kidney Diseases, run by Istituto Nazionale di Ricovero e Cura per Anziani at 9 sites in 7 countries.
Trial summary
The SCOPE study is an observational, multicenter, prospective cohort study aimed at evaluating a 2-year screening programme for CKD in a population of older patients, aged 75 years or more, in seven European Countries, in an attempt to investigate whether and to which extent currently available screening methods may… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- blood sample collection
- How many people
- 2,434 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 8 Aug 2016to 10 Mar 2020
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: subjects with 75 years or older
Who may be able to join
- age≥75 years
- subjects attending the outpatient services at participating institutions
Who cannot join
- ESRD or dialysis
- history of solid organ or bone marrow transplantation
- active malignancy within 24 months prior to screening or metastatic cancer
- life expectancy less than 6 months
- severe cognitive impairment (MMSE<10),
- any medical or other reason that the subject is unsuitable for the study
- subjects unwilling to provide consent
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
Italy2 sites
INRCA Research Hospital
Ancona, 60131
INRCA Research Hospital
Cosenza
Spain2 sites
INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment
Barcelona, 08007
SERVICIO MADRILENO DE SALUD-Geriatric Department
Madrid, 28020
Austria1 site
MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department
Graz, 8036
Germany1 site
FRIEDRICH-ALEXANDER-UNIVERSITAT-Institute for Biomedicine of Aging
Erlangen, 91054
Netherlands1 site
ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine
Rotterdam, 3015CE
About this study
The SCOPE study is an observational, multicenter, prospective cohort study aimed at evaluating a 2-year screening programme for CKD in a population of older patients, aged 75 years or more, in seven European Countries, in an attempt to investigate whether and to which extent currently available screening methods may identify older people at risk of worsening kidney function.
- Conditions
- Chronic Kidney Diseases
- Being tested
- blood sample collection
- Keywords
- Chronic Kidney Diseases, Older, Geriatric assessment, Biomarkers
- 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.
blood sample collectionOther
| Study group | Role | What they receive |
|---|---|---|
| Subjects aged 75 years or older | Not described Receives: Other: blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of estimated Glomerular Filtration Rate (eGFR) decline
eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation
Measured: 24 months
Incidence of End Stage Renal Disease (ESRD)
ESRD will be defined as eGFR<15 mL/min/1.73 m2 or dialysis
Measured: 24 months
Secondary outcomes (7)
Biomarkers of kidney function
cystatin C, beta2-microglobulin, beta-trace protein
Measured: Baseline and 24 months
Genetic and epigenetic analyses
circulating microRNA, telomere length in circulating leukocytes, DNA methylation, analysis of the whole genome
Measured: Baseline and 24 months
Incidence of CKD complications
anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia
Measured: 24 months
Incidence of major comorbidities
myocardial infarction, hospitalization for unstable angina, transient ischemic attack/stroke, heart failure events, interventional cardiology events, peripheral vascular intervention, and stent thrombosis
Measured: 24 months
Cardiovascular mortality
death resulting from acute myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures, CV hemorrhage, and other CV causes
Measured: 24 months
Comprehensive geriatric assessment (CGA)
Cognitive function (Mini Mental State Examination), depression (Geriatric Depression Scale), functional assessment (Basic Activity of Daily Living, Lawton Instrumental Activities of Daily Living Scale), health status (Cumulative Illness Rating Scale for Geriatrics), risk of malnutrition (Mini Nutritional Assessment), dietary intake assessment (24-h Dietary Recall), history of falls and incident falls, vision and hearing impairment, socioeconomic Status, physical Performance (Short Physical Performance Battery Test), muscle strength (Hand Grip Strength), quality of life (Euro-Qol 5D)
Measured: Baseline and 24 months
Healthcare resource consumption
previous physician visits, use of care services, hospital admissions, laboratory tests performed
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study start8 Aug 2016
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Prospective
- Enrolment
- 2,434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev, Erasmus Medical Center, Medical University of Graz, Servicio Madrileño de Salud, Madrid, Spain, Institut Catala de Salut, UNIVERSYTET MEDYCZNY W LODZI, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uppsala University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691546
- Sponsor's protocol ID
- INRCA_01_2016
- Other IDs
- Grant Agreement n. 634869
- Acronym
- SCOPE
- Status last verified
- Feb 2016
- First submitted
- 20 Feb 2016
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Freiberger E, Fabbietti P, Corsonello A, Lattanzio F, Sieber C, Tap L, Mattace-Raso F, Arnlov J, Carlsson AC, Roller-Wirnsberger R, Wirnsberger G, Moreno-Gonzalez R, Formiga F, Martinez SL, Gil P, Kostka T, Guligowska A, Yehoshua I, Melzer I, Kob R; SCOPE investigators. Short physical performance battery is not associated with falls and injurious falls in older persons: longitudinal data of the SCOPE project. Eur Geriatr Med. 2024 Jun;15(3):831-842. doi: 10.1007/s41999-024-00941-y. Epub 2024 Feb 28.
PubMed 38416398Freiberger E, Fabbietti P, Corsonello A, Lattanzio F, Artzi-Medvedik R, Kob R, Melzer I; SCOPE consortium; Britting S. Transient versus stable nature of fear of falling over 24 months in community-older persons with falls- data of the EU SCOPE project on Kidney function. BMC Geriatr. 2022 Aug 23;22(1):698. doi: 10.1186/s12877-022-03357-0.
PubMed 35999522Tap L, Corsonello A, Formiga F, Moreno-Gonzalez R, Arnlov J, Carlsson AC, Roller-Wirnsberger R, Wirnsberger G, Ziere G, Freiberger E, Sieber C, Kostka T, Guligowska A, Gil P, Martinez SL, Artzi-Medvedik R, Yehoshua I, Fabbietti P, Lattanzio F, Mattace-Raso F; SCOPE investigators. Is kidney function associated with cognition and mood in late life? : The Screening for CKD among Older People across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):297. doi: 10.1186/s12877-020-01707-4.
PubMed 33008359Britting S, Artzi-Medvedik R, Fabbietti P, Tap L, Mattace-Raso F, Corsonello A, Lattanzio F, Arnlov J, Carlsson AC, Roller-Wirnsberger R, Wirnsberger G, Kostka T, Guligowska A, Formiga F, Moreno-Gonzalez R, Gil P, Martinez SL, Kob R, Melzer I, Freiberger E; SCOPE investigators. Kidney function and other factors and their association with falls : The screening for CKD among older people across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):320. doi: 10.1186/s12877-020-01698-2.
PubMed 33008307Corsonello A, Fabbietti P, Formiga F, Moreno-Gonzalez R, Tap L, Mattace-Raso F, Roller-Wirnsberger R, Wirnsberger G, Arnlov J, Carlsson AC, Weingart C, Freiberger E, Kostka T, Guligowska A, Gil P, Martinez SL, Melzer I, Yehoshua I, Lattanzio F; SCOPE investigators. Chronic kidney disease in the context of multimorbidity patterns: the role of physical performance : The screening for CKD among older people across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):350. doi: 10.1186/s12877-020-01696-4.
PubMed 33008303Corsonello A, Tap L, Roller-Wirnsberger R, Wirnsberger G, Zoccali C, Kostka T, Guligowska A, Mattace-Raso F, Gil P, Fuentes LG, Meltzer I, Yehoshua I, Formiga-Perez F, Moreno-Gonzalez R, Weingart C, Freiberger E, Arnlov J, Carlsson AC, Bustacchini S, Lattanzio F; SCOPE investigators. Design and methodology of the screening for CKD among older patients across Europe (SCOPE) study: a multicenter cohort observational study. BMC Nephrol. 2018 Oct 11;19(1):260. doi: 10.1186/s12882-018-1030-2.
PubMed 30309342
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE)
- ClinicalTrials.gov ID
- NCT02691546
- Acronym / sponsor ID
- SCOPE / INRCA_01_2016
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Diseases, Older, Geriatric assessment, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,434 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev, Erasmus Medical Center, Medical University of Graz, Servicio Madrileño de Salud, Madrid, Spain, Institut Catala de Salut, UNIVERSYTET MEDYCZNY W LODZI, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uppsala University
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 25 Feb 2016 (estimated)
- 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 SCOPE study is an observational, multicenter, prospective cohort study aimed at evaluating a 2-year screening programme for CKD in a population of older patients, aged 75 years or more, in seven European Countries, in an attempt to investigate whether and to which extent currently available screening methods may identify older people at risk of worsening kidney function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects aged 75 years or older | – | Other: blood sample collection |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- subjects with 75 years or older
Key inclusion criteria (2 listed)
- age≥75 years
- subjects attending the outpatient services at participating institutions
Key exclusion criteria (7 listed)
- ESRD or dialysis
- history of solid organ or bone marrow transplantation
- active malignancy within 24 months prior to screening or metastatic cancer
- life expectancy less than 6 months
- severe cognitive impairment (MMSE<10),
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 |
|---|---|---|
| blood sample collection | Other | Subjects aged 75 years or older |
Primary outcome
Rate of estimated Glomerular Filtration Rate (eGFR) decline
Time frame: 24 months
eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation
Incidence of End Stage Renal Disease (ESRD)
Time frame: 24 months
ESRD will be defined as eGFR<15 mL/min/1.73 m2 or dialysis
7 secondary outcomes
Biomarkers of kidney function
Time frame: Baseline and 24 months
Genetic and epigenetic analyses
Time frame: Baseline and 24 months
Incidence of CKD complications
Time frame: 24 months
Incidence of major comorbidities
Time frame: 24 months
Cardiovascular mortality
Time frame: 24 months
Comprehensive geriatric assessment (CGA)
Time frame: Baseline and 24 months
Healthcare resource consumption
Time frame: Baseline and 24 months
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 24 Jun 2020.
- Derived from this study: PubMed 38416398Freiberger E, Fabbietti P, Corsonello A, Lattanzio F, Sieber C, Tap L, Mattace-Raso F, Arnlov J, Carlsson AC, Roller-Wirnsberger R, Wirnsberger G, Moreno-Gonzalez R, Formiga F, Martinez SL, Gil P, Kostka T, Guligowska A, Yehoshua I, Melzer I, Kob R; SCOPE investigators. Short physical performance battery is not associated with falls and injurious falls in older persons: longitudinal data of the SCOPE project. Eur Geriatr Med. 2024 Jun;15(3):831-842. doi: 10.1007/s41999-024-00941-y. Epub 2024 Feb 28.
- Derived from this study: PubMed 35999522Freiberger E, Fabbietti P, Corsonello A, Lattanzio F, Artzi-Medvedik R, Kob R, Melzer I; SCOPE consortium; Britting S. Transient versus stable nature of fear of falling over 24 months in community-older persons with falls- data of the EU SCOPE project on Kidney function. BMC Geriatr. 2022 Aug 23;22(1):698. doi: 10.1186/s12877-022-03357-0.
- Derived from this study: PubMed 33008359Tap L, Corsonello A, Formiga F, Moreno-Gonzalez R, Arnlov J, Carlsson AC, Roller-Wirnsberger R, Wirnsberger G, Ziere G, Freiberger E, Sieber C, Kostka T, Guligowska A, Gil P, Martinez SL, Artzi-Medvedik R, Yehoshua I, Fabbietti P, Lattanzio F, Mattace-Raso F; SCOPE investigators. Is kidney function associated with cognition and mood in late life? : The Screening for CKD among Older People across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):297. doi: 10.1186/s12877-020-01707-4.
- Derived from this study: PubMed 33008307Britting S, Artzi-Medvedik R, Fabbietti P, Tap L, Mattace-Raso F, Corsonello A, Lattanzio F, Arnlov J, Carlsson AC, Roller-Wirnsberger R, Wirnsberger G, Kostka T, Guligowska A, Formiga F, Moreno-Gonzalez R, Gil P, Martinez SL, Kob R, Melzer I, Freiberger E; SCOPE investigators. Kidney function and other factors and their association with falls : The screening for CKD among older people across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):320. doi: 10.1186/s12877-020-01698-2.
- Derived from this study: PubMed 33008303Corsonello A, Fabbietti P, Formiga F, Moreno-Gonzalez R, Tap L, Mattace-Raso F, Roller-Wirnsberger R, Wirnsberger G, Arnlov J, Carlsson AC, Weingart C, Freiberger E, Kostka T, Guligowska A, Gil P, Martinez SL, Melzer I, Yehoshua I, Lattanzio F; SCOPE investigators. Chronic kidney disease in the context of multimorbidity patterns: the role of physical performance : The screening for CKD among older people across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):350. doi: 10.1186/s12877-020-01696-4.
- Derived from this study: PubMed 30309342Corsonello A, Tap L, Roller-Wirnsberger R, Wirnsberger G, Zoccali C, Kostka T, Guligowska A, Mattace-Raso F, Gil P, Fuentes LG, Meltzer I, Yehoshua I, Formiga-Perez F, Moreno-Gonzalez R, Weingart C, Freiberger E, Arnlov J, Carlsson AC, Bustacchini S, Lattanzio F; SCOPE investigators. Design and methodology of the screening for CKD among older patients across Europe (SCOPE) study: a multicenter cohort observational study. BMC Nephrol. 2018 Oct 11;19(1):260. doi: 10.1186/s12882-018-1030-2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Istituto Nazionale di Ricovero e Cura per Anziani at 9 sites in 7 countries.
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 2 inclusion and 7 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 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Spain, Austria, Germany, Israel and 2 more countries. 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?
Rate of estimated Glomerular Filtration Rate (eGFR) decline (time frame: 24 months). 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?
On the ClinicalTrials.gov record for NCT02691546, which also lists 6 linked publications.
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 24 Jun 2020.