NCT02691546

Brief 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 identify older people at risk of worsening kidney function.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,434

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
7 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

August 8, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

June 24, 2020

Status Verified

February 1, 2016

Enrollment Period

3.6 years

First QC Date

February 20, 2016

Last Update Submit

June 23, 2020

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney DiseasesOlderGeriatric assessmentBiomarkers

Outcome Measures

Primary Outcomes (2)

  • Rate of estimated Glomerular Filtration Rate (eGFR) decline

    eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation

    24 months

  • Incidence of End Stage Renal Disease (ESRD)

    ESRD will be defined as eGFR\<15 mL/min/1.73 m2 or dialysis

    24 months

Secondary Outcomes (7)

  • Biomarkers of kidney function

    Baseline and 24 months

  • Genetic and epigenetic analyses

    Baseline and 24 months

  • Incidence of CKD complications

    24 months

  • Incidence of major comorbidities

    24 months

  • Cardiovascular mortality

    24 months

  • +2 more secondary outcomes

Study Arms (1)

Subjects aged 75 years or older

Other: blood sample collection

Interventions

blood sample collectionOTHER
Subjects aged 75 years or older

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects with 75 years or older

You may qualify if:

  • age≥75 years
  • subjects attending the outpatient services at participating institutions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department

Graz, 8036, Austria

Location

FRIEDRICH-ALEXANDER-UNIVERSITAT-Institute for Biomedicine of Aging

Erlangen, 91054, Germany

Location

BEN-GURION UNIVERSITY-Geriatrics Department

Beersheba, 84105, Israel

Location

INRCA Research Hospital

Ancona, 60131, Italy

Location

INRCA Research Hospital

Cosenza, Italy

Location

ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine

Rotterdam, 3015CE, Netherlands

Location

UNIVERSYTET MEDYCZNY-Department of Geriatrics

Lodz, 90419, Poland

Location

INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment

Barcelona, 08007, Spain

Location

SERVICIO MADRILENO DE SALUD-Geriatric Department

Madrid, 28020, Spain

Location

Related Publications (6)

  • 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.

    PMID: 38416398DERIVED

  • Freiberger 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.

    PMID: 35999522DERIVED

  • Tap 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.

    PMID: 33008359DERIVED

  • Britting 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.

    PMID: 33008307DERIVED

  • Corsonello 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.

    PMID: 33008303DERIVED

  • Corsonello 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.

    PMID: 30309342DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, whole blood

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2016

First Posted

February 25, 2016

Study Start

August 8, 2016

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

June 24, 2020

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)ES(2)DE(1)NL(1)AU(1)IL(1)PL(1)