Chronic Kidney DiseasesSCOPE-PLUSNCT04449172
ProtocoL for GFR Measurement Using Iohexol (SCOPE-PLUS) - A Substudy of the SCOPE Study
An observational study of Chronic Kidney Diseases, run by Istituto Nazionale di Ricovero e Cura per Anziani at 5 sites in 4 countries.
Trial summary
SCOPE-PLUS is an optional substudy of the observational SCOPE Study (Screening for Chronic Kidney Disease among Older People across Europe, NCT02691546). The objective of the SCOPE-PLUS study is to derive new equations based on innovative and novel biomarkers of CKD function and compare its accuracy to measure GFR in… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 100 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 8 Aug 2019to 30 Aug 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 75 years and older
- All sexes
- Older adult
Study population: subjects with 75 years or older previously enrolled in the SCOPE study (NCT02691546)
Who may be able to join
- to be eligible for this study, subjects must have been enrolled in the SCOPE study
Who cannot join
- a thyroid-stimulating hormone level less than 0.3 mlU/L
- a known iodine allergy
- oedema
- ascites
- clinically symptomatic heart failure
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Italy2 sites
INRCA Research Hospital
Ancona, 60131
INRCA Research Hospital
Cosenza
Austria1 site
MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department
Graz, 8036
Netherlands1 site
ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine
Rotterdam, 3015CE
Spain1 site
INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment
Barcelona, 08007
About this study
SCOPE-PLUS is an optional substudy of the observational SCOPE Study (Screening for Chronic Kidney Disease among Older People across Europe, NCT02691546). The objective of the SCOPE-PLUS study is to derive new equations based on innovative and novel biomarkers of CKD function and compare its accuracy to measure GFR in the population older than 75 years.
Read the detailed description
SCOPE-PLUS is an optional substudy of the SCOPE cohort study (Screening for Chronic Kidney Disease among Older People across Europe, NCT02691546). SCOPE has retrieved data on a wide panel of biomarkers of CKD in a large study cohort enrolling about 2,450 older people in Italy, Spain, Germany, Austria, Netherlands, Poland and Israel. The innovative biomarkers have been already validated by the literature, and include e.g. Cystatin C (CysC), β-Trace protein (BTP), and Beta2-microglobulin. Others promising novel biomarkers of CKD, based on metabolomic and proteomic determinations or other techniques have been evaluated. The objective of the SCOPE-plus study is to to verify the accuracy of newly developed equations based on innovative and novel biomarkers of CKD function by calculating the percentage of estimates within 30% (P30) of the measured GFR (mGFR). The mGFR will be obtained by the assessment of nonradioactive iohexol clearance. Patients previously enrolled in the SCOPE study, are invited to participate in this additional protocol. Iohexol is an iodinated contrast medium with characteristics similar to those of inulin, being freely filtered by the glomerulus, neither secreted nor reabsorbed by the renal tubules and recovered almost 100% in the urine. These characteristics made it an ideal agent for the determination of the renal function.
- Conditions
- Chronic Kidney Diseases
- Keywords
- glomerular filtration rate, older people, ioexol
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure GFR in subjects aged 75 or older by iohexol clearance to verify the accuracy of equations of innovative and novel biomarkers of CKD newly evaluated in the SCOPE study
Iohexol solution 5 mL (Omnipaque, GE Healthcare), containing 3235 mg of iohexol will be administered intravenously into an antecubital, forearm, or hand vein and flushed with 10 mL of normal saline. Blood samples for serum creatinine and other biomarkers will be obtained before iohexol is applied. Blood samples will be obtained after 5 minutes from the contralateral arm to confirm that the Iohexol has been administered correctly intravenously. Subsequent blood sample will be collected (always from the contralateral arm) at 10, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes after injection. The exact timing of the samples collection will be recorded. All clearance measurements will be started between 8:00 and 10:30 a.m.
Measured: 300 minutes from intravenous injection of iohexol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start8 Aug 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Institut Catala de Salut, Medical University of Graz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449172
- Sponsor's protocol ID
- INRCA_05_2019
- Other IDs
- Grant Agreement n. 634869
- Acronym
- SCOPE-PLUS
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProtocoL for GFR Measurement Using Iohexol (SCOPE-PLUS) - A Substudy of the SCOPE Study
- ClinicalTrials.gov ID
- NCT04449172
- Acronym / sponsor ID
- SCOPE-PLUS / INRCA_05_2019
- Conditions
- Chronic Kidney Diseases
- Keywords
- glomerular filtration rate, older people, ioexol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Institut Catala de Salut, Medical University of Graz
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 26 Jun 2020 (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.
SCOPE-PLUS is an optional substudy of the observational SCOPE Study (Screening for Chronic Kidney Disease among Older People across Europe, NCT02691546). The objective of the SCOPE-PLUS study is to derive new equations based on innovative and novel biomarkers of CKD function and compare its accuracy to measure GFR in the population older than 75 years.
Detailed description
SCOPE-PLUS is an optional substudy of the SCOPE cohort study (Screening for Chronic Kidney Disease among Older People across Europe, NCT02691546). SCOPE has retrieved data on a wide panel of biomarkers of CKD in a large study cohort enrolling about 2,450 older people in Italy, Spain, Germany, Austria, Netherlands, Poland and Israel. The innovative biomarkers have been already validated by the literature, and include e.g. Cystatin C (CysC), β-Trace protein (BTP), and Beta2-microglobulin. Others promising novel biomarkers of CKD, based on metabolomic and proteomic determinations or other techniques have been evaluated. The objective of the SCOPE-plus study is to to verify the accuracy of newly developed equations based on innovative and novel biomarkers of CKD function by calculating the percentage of estimates within 30% (P30) of the measured GFR (mGFR). The mGFR will be obtained by the assessment of nonradioactive iohexol clearance. Patients previously enrolled in the SCOPE study, are invited to participate in this additional protocol. Iohexol is an iodinated contrast medium with characteristics similar to those of inulin, being freely filtered by the glomerulus, neither secreted nor reabsorbed by the renal tubules and recovered almost 100% in the urine. These characteristics made it an ideal agent for the determination of the renal function.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- subjects with 75 years or older previously enrolled in the SCOPE study (NCT02691546)
Key inclusion criteria (1 listed)
- to be eligible for this study, subjects must have been enrolled in the SCOPE study
Key exclusion criteria (5 listed)
- a thyroid-stimulating hormone level less than 0.3 mlU/L
- a known iodine allergy
- oedema
- ascites
- clinically symptomatic heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure GFR in subjects aged 75 or older by iohexol clearance to verify the accuracy of equations of innovative and novel biomarkers of CKD newly evaluated in the SCOPE study
Time frame: 300 minutes from intravenous injection of iohexol
Iohexol solution 5 mL (Omnipaque, GE Healthcare), containing 3235 mg of iohexol will be administered intravenously into an antecubital, forearm, or hand vein and flushed with 10 mL of normal saline. Blood samples for serum creatinine and other biomarkers will be obtained before iohexol is applied. Blood samples will be obtained after 5 minutes from the contralateral arm to confirm that the Iohexol has been administered correctly intravenously. Subsequent blood sample will be collected (always from the contralateral arm) at 10, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes after injection. The exact timing of the samples collection will be recorded. All clearance measurements will be started between 8:00 and 10:30 a.m.
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 5 Mar 2024.
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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.
5 sites in 4 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 5 sites in 4 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 1 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Austria, Netherlands, Spain. 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?
To measure GFR in subjects aged 75 or older by iohexol clearance to verify the accuracy of equations of innovative and novel biomarkers of CKD newly evaluated in the SCOPE study (time frame: 300 minutes from intravenous injection of iohexol). 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 5 Mar 2024.