ClinicalTrials.gov
ClinicalTrials.gov Menu

Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE) (SCOPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02691546
Recruitment Status : Unknown
Verified February 2016 by Istituto Nazionale di Ricovero e Cura per Anziani.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2016
Last Update Posted : February 25, 2016
Sponsor:
Collaborators:
Ben-Gurion University of the Negev
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Medical University of Graz
Servicio Madrileño de Salud, Madrid, Spain
INSTITUT CATALA DE LA SALUT
UNIVERSYTET MEDYCZNY W LODZI
FRIEDRICH-ALEXANDER-UNIVERSITAT ERLANGEN NURNBERG
UPPSALA UNIVERSITET
Information provided by (Responsible Party):
Istituto Nazionale di Ricovero e Cura per Anziani

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.

Condition or disease Intervention/treatment
Chronic Kidney Diseases Other: blood sample collection

Study Type : Observational
Estimated Enrollment : 2450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE)
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects aged 75 years or older Other: blood sample collection



Primary Outcome Measures :
  1. Rate of estimated Glomerular Filtration Rate (eGFR) decline [ Time Frame: 24 months ]
    eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation

  2. 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


Secondary Outcome Measures :
  1. Biomarkers of kidney function [ Time Frame: Baseline and 24 months ]
    cystatin C, beta2-microglobulin, beta-trace protein

  2. Genetic and epigenetic analyses [ Time Frame: Baseline and 24 months ]
    circulating microRNA, telomere length in circulating leukocytes, DNA methylation, analysis of the whole genome

  3. Incidence of CKD complications [ Time Frame: 24 months ]
    anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia

  4. Incidence of major comorbidities [ Time Frame: 24 months ]
    myocardial infarction, hospitalization for unstable angina, transient ischemic attack/stroke, heart failure events, interventional cardiology events, peripheral vascular intervention, and stent thrombosis

  5. Cardiovascular mortality [ Time Frame: 24 months ]
    death resulting from acute myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures, CV hemorrhage, and other CV causes

  6. Comprehensive geriatric assessment (CGA) [ Time Frame: Baseline and 24 months ]
    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)

  7. Healthcare resource consumption [ Time Frame: Baseline and 24 months ]
    previous physician visits, use of care services, hospital admissions, laboratory tests performed


Biospecimen Retention:   Samples With DNA
plasma, serum, whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subjects with 75 years or older
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691546


Contacts
Contact: Fabrizia Lattanzio 0039 0718004622 f.lattanzio@inrca.it
Contact: Silvia Bustacchini 0039 0718004613 s.bustacchini@inrca.it

Locations
Austria
MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department Not yet recruiting
Graz, Austria, 8036
Contact: GERHARD WIRNSBERGER    0043 316 385 80    gerhard.wirnsberger@medunigraz.at   
Germany
FRIEDRICH-ALEXANDER-UNIVERSITAT-Institute for Biomedicine of Aging Not yet recruiting
Erlangen, Germany, 91054
Contact: Cornel Sieber, Prof.    0049 11530296160    cornel.sieber@fau.de   
Israel
BEN-GURION UNIVERSITY-Geriatrics Department Not yet recruiting
Beer Sheva, Israel, 84105
Contact: Avram Mark Clarfield    0097 286479912    markclar@bgu.ac.il   
Italy
INRCA Research Hospital Not yet recruiting
Ancona, Italy, 60131
Contact: Fabrizia Lattanzio    0039 0718004622    f.lattanzio@inrca.it   
INRCA Research Hospital Not yet recruiting
Cosenza, Italy
Contact: Andrea Corsonello    0039 0984682343    a.corsonello@inrca.it   
Netherlands
ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine Not yet recruiting
Rotterdam, Netherlands, 3015CE
Contact: Francesco Mattace Raso    0031 10 703 59 79    f.mattaceraso@erasmusmc.nl   
Poland
UNIVERSYTET MEDYCZNY-Department of Geriatrics Not yet recruiting
Lodz, Poland, 90419
Contact: TOMASZ KOSTKA    0048 426393215    tomasz.kostka@umed.lodz.pl   
Spain
INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment Not yet recruiting
Barcelona, Spain, 08007
Contact: FRANCESC FORRMIGA    0034 93 260 7419    fformiga@bellvitgehospital.cat   
SERVICIO MADRILENO DE SALUD-Geriatric Department Not yet recruiting
Madrid, Spain, 28020
Contact: PEDRO GIL    0034 913 303 305    pgil@salud.madrid.org   
Sponsors and Collaborators
Istituto Nazionale di Ricovero e Cura per Anziani
Ben-Gurion University of the Negev
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Medical University of Graz
Servicio Madrileño de Salud, Madrid, Spain
INSTITUT CATALA DE LA SALUT
UNIVERSYTET MEDYCZNY W LODZI
FRIEDRICH-ALEXANDER-UNIVERSITAT ERLANGEN NURNBERG
UPPSALA UNIVERSITET

Responsible Party: Istituto Nazionale di Ricovero e Cura per Anziani
ClinicalTrials.gov Identifier: NCT02691546     History of Changes
Other Study ID Numbers: INRCA_01_2016
Grant Agreement n. 634869 ( Other Grant/Funding Number: European Commission-Horizon 2020 )
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Istituto Nazionale di Ricovero e Cura per Anziani:
Chronic Kidney Diseases
Older
Geriatric assessment
Biomarkers

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency