Chronic Kidney DiseasesRESPECTNCT05229263
Multiparametric MRI in Healthy Volunteers and CKD Patients
A study testing Non- contrast Enhanced Multiparametric Renal Magnetic Resonance in people with Chronic Kidney Diseases and Healthy, run by Mario Negri Institute for Pharmacological Research at 4 sites in 4 countries.
Trial summary
Chronic kidney disease (CKD) is a global health concern because more than 10% of the world's population have it, its prevalence is increasing, and CKD is an important contributor to morbidity and mortality for this population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Healthy
- What is being tested?
- Non- contrast Enhanced Multiparametric Renal Magnetic Resonance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 25 Nov 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- GROUP 1:
- Provision of written informed consent prior to any study specific procedures
- Male and female subjects aged more than18 years
- Normotensive (office Systolic Blood Pressure values < 140 mmHg and Diastolic Blood Pressure values ≤ 90 mmHg)
- Normal renal condition for age (established by estimating Glomerular Filtration Rate using CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration, Creatinine Equation)
- Negative result upon urine dipstick testing for haematuria or proteinuria.
Show all 11Show fewer
- Normal Urine Albumin-to-Creatinine Ratio (UACR) (<30 mg/g)
- GROUP 2:
- Provision of written informed consent prior to any study specific procedures
- Male and female patients aged more than18 years
- CKD stage 2 or 3, with albuminuria up to 2000 mg
Who cannot join
- GROUP 1 and 2
- Previous enrollment in the present study
- Contraindications to MRI including due to:
- Claustrophobia
- Pregnancy
- Cardiac pacemakers or other MRI-incompatible prostheses
Show all 15Show fewer
- Only GROUP 2:
- Urine Albumin-to-Creatinine Ratio higher than 2000 mg/g or 24h urine total albumin >2 g
- Polycystic kidney disease, renovascular disease, active/current nephrotic syndrome, reflux nephropathy and known congenital renal diseases or solitary kidney.
- Active malignancy or acute or chronic inflammatory disease, HIV
- Acute kidney injury, as defined by the the KDIGO guidelines, during the last three months.
- Need of a new immunosuppressive therapy for treating renal disease relapse in the preceding three months.
- Dialysis or kidney transplantation
- CKD stages 4 or 5
- New medication in the preceding two weeks (diuretic, hypertensive, SGLT2 treatment)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Denmark1 site
Aarhus University Hospital, Department of Renal Medicine
Århus N, Århus N, 8200
Germany1 site
University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University
Heidelberg, Mannheim
Italy1 site
Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"
Ranica, BG, 24020
About this study
Official title: Exploratory Multicentre Clinical Study to Assess Repeatibility, Reproducibility, Acceptability and Clinical Validity of Multiparametric Renal Magnetic Resonance Imaging
Chronic kidney disease (CKD) is a global health concern because more than 10% of the world's population have it, its prevalence is increasing, and CKD is an important contributor to morbidity and mortality for this population.
The majority of the people with CKD aren't aware and there are not available tools for early CKD detection and for an accurate prediction on these patients. Many CKD patients exhibit progressive renal dysfunction, demonstrating a failure of current, non-specific therapeutic strategies. Better methods are urgently needed for i) early diagnosis of CKD, and prediction of its progression for improved stratification of patients and better targeting of current treatments; and ii) to directly assess structural and functional responses of the kidney to new therapies and identify those patients who respond.
Read more
Over the past decade, renal Magnetic Resonance Imaging (MRI) has emerged as a promising technique for improved understanding and characterisation of renal pathophysiology. Compared to histopathology, MRI is non-invasive and avoids sampling bias by characterising the entire kidney with high spatial resolution.
In spite of a number of single centre studies showing renal MRI feasibility and potential to address a number of key clinical questions, current methodological differences across studies hinder reliable comparisons of the results, which can only be regarded as preliminary. Standardization of acquisition and processing protocols across centres is therefore needed, and this will also lead to the possibility to provide preliminary data of the multiparametric renal MRI clinical validity and utility.
The purpose of this study is to standardize, assess the feasibility and provide preliminary evidence of clinical validity and utility of the multiparametric renal MRI.
To reach this goal two groups of subjects are involved:
- Group 1 (healthy volunteers). In this group the repeatibility and reproducibility of multiparametric renal MRI will be assessed.
- Group 2 (CKD patients). In this group the feasibility, the acceptability, the reproducibility and the preliminary clinical validity of multiparametric renal MRI will be assessed.
- Conditions
- Chronic Kidney Diseases, Healthy
- Being tested
- Non- contrast Enhanced Multiparametric Renal Magnetic Resonance
- Keywords
- Multiparametric MRI, Chronic kidney disease, Standardization, Clinical validity
- 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.
Non- contrast Enhanced Multiparametric Renal Magnetic ResonanceDiagnostic test
MRI is performed in a single multiparametric scan session with no need for contrast agents, and to depict changes in tissue microstructure associated with inflammation and fibrosis plus alterations in oxygenation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Not described Receives: Diagnostic Test: Non- contrast Enhanced Multiparametric Renal Magnetic Resonance |
| CKD patients | Experimental | Not described Receives: Diagnostic Test: Non- contrast Enhanced Multiparametric Renal Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
GROUP 1: within subject total kidney volume coefficient of variation in few hour time
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess total kidney volume repeatability in the whole group of healthy volunteers
Measured: At day 0
GROUP 1: within subject total kidney volume coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess total kidney volume reproducibility in the whole group of healthy volunteers
Measured: At day 7-14
GROUP 1: within subject renal artery blood flow coefficient of variation in few hour time
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess renal artery blood flow repeatability in the whole group of healthy volunteers
Measured: At day 0
GROUP 1: within subject renal artery blood flow coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess renal artery blood flow reproducibility in the whole group of healthy volunteers
Measured: At day 7-14
GROUP 1: within subject cortical perfusion coefficient of variation in few hour time
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical perfusion repeatability in the whole group of healthy volunteers
Measured: At day 0
GROUP 1: within subject cortical perfusion coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical perfusion reproducibility in the whole group of healthy volunteers
Measured: At day 7-14
GROUP 1: within subject cortical and medullary T1 coefficient of variation in few hour time
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary T1 repeatability in the whole group of healthy volunteers
Measured: At day 0
GROUP 1: within subject cortical and medullary T1 coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T1 reproducibility in the whole group of healthy volunteers
Measured: At day 7-14
GROUP 1: within subject cortical and medullary T2 coefficient of variation in few hour time
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary T2 repeatability in the whole group of healthy volunteers
Measured: At day 0
GROUP 1: within subject cortical and medullary T2 coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T2 reproducibility in the whole group of healthy volunteers
Measured: At day 7-14
GROUP 1: within subject cortical and medullary R2* coefficient of variation in few hour time
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary R2* repeatability in the whole group of healthy volunteers
Measured: At day 0
GROUP 1: within subject cortical and medullary R2* coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary R2* reproducibility in the whole group of healthy volunteers
Measured: At day 7-14
GROUP 1: within subject cortical and medullary ADC coefficient of variation in few hour time
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary ADC repeatability in the whole group of healthy volunteers
Measured: At day 0
GROUP 1: within subject cortical and medullary ADC coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary ADC reproducibility in the whole group of healthy volunteers
Measured: At day 7-14
GROUP 2 - Percentage of complete renal MRI data collection and analysis
Percentage of complete renal MRI data acquired and generated by MRI data processing in the whole group of CKD patients, to assess feasibility of multiparametric renal MRI in CKD patients
Measured: At day 0
Secondary outcomes (38)
GROUP 1 - within subject renal total kidney volume coefficient of variation in few hour time by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in total kidney volume repeatability between genders
Measured: At day 0
GROUP 1 - within subject renal artery blood flow coefficient of variation in few hour time by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in renal artery blood flow repeatability between genders
Measured: At day 0
GROUP 1 - within subject cortical perfusion coefficient of variation in few hour time by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical perfusion repeatability between genders
Measured: At day 0
GROUP 1 - within subject cortical and medullary T1 coefficient of variation in few hour time by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical and medullary T1 repeatability between genders
Measured: At day 0
GROUP 1 - within subject cortical and medullary T2 coefficient of variation in few hour time by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical and medullary T2 repeatability between genders
Measured: At day 0
GROUP 1 - within subject cortical and medullary R2* coefficient of variation in few hour time by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical and medullary R2* repeatability between genders
Measured: At day 0
GROUP 1 - within subject cortical and medullary ADC coefficient of variation in few hour time by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in male and female healthy volunteers to assess differences in cortical and medullary ADC repeatability between genders
Measured: At day 0
GROUP 1 - within subject total kidney volume coefficient of variation in few hour time by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in total kidney volume repeatability between age classes
Measured: At day 0
GROUP 1 - within subject renal artery blood flow coefficient of variation in few hour time by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess difference in renal artery blood flow repeatability between age classes
Measured: At day 0
GROUP 1 - within subject cortical perfusion coefficient of variation in few hour time by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical perfusion repeatability between age classes
Measured: At day 0
GROUP 1 - within subject cortical and medullary T1 coefficient of variation in few hour time by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical and medullary T1 repeatability between age classes
Measured: At day 0
GROUP 1 - within subject cortical and medullary T2 coefficient of variation in few hour time by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical and medullary T2 repeatability between age classes
Measured: At day 0
GROUP 1 - within subject cortical and medullary R2* coefficient of variation in few hour time by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical and medullary R2* repeatability between age classes
Measured: At day 0
GROUP 1 - within subject cortical and medullary ADC coefficient of variation in few hour time by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time in healthy volunteers of different age to assess differences in cortical and medullary ADC repeatability between age classes
Measured: At day 0
GROUP 1 - within subject total kidney volume coefficient of variation after 1-2 weeks by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in total kidney volume reproducibility between genders
Measured: At day 7-14
GROUP 1 - within subject renal artery blood flow coefficient of variation after 1-2 weeks by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in renal artery blood flow reproducibility between genders
Measured: At day 7-14
GROUP 1 - within subject cortical perfusion coefficient of variation after 1-2 weeks by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in cortical perfusion reproducibility between genders
Measured: At day 7-14
GROUP 1 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess difference in cortical and medullary T1 reproducibility between genders
Measured: At day 7-14
GROUP 1 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in cortical and medullary T2 reproducibility between genders
Measured: At day 7-14
GROUP 1 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in cortical and medullary R2* reproducibility between genders
Measured: At day 7-14
GROUP 1 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks by gender
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in male and female healthy volunteers to assess differences in cortical and medullary ADC reproducibility between genders
Measured: At day 7-14
GROUP 1 - within subject total kidney volume coefficient of variation after 1-2 weeks by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in healthy volunteers of different age to assess differences in total kidney volume reproducibility between age classes
Measured: At day 7-14
GROUP 1 - within subject renal artery blood flow coefficient of variation after 1-2 weeks by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks in healthy volunteers of different age to assess differences in renal artery blood flow reproducibility between age classes
Measured: At day 7-14
GROUP 1 - within subject cortical perfusion coefficient of variation after 1-2 weeks by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical perfusion reproducibility between age classes
Measured: At day 7-14
GROUP 1 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical and medullary T1 reproducibility between age classes
Measured: At day 7-14
GROUP 1 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical and medullary T2 reproducibility between age classes
Measured: At day 7-14
GROUP 1 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical and medullary R2* reproducibility between age classes
Measured: At day 7-14
GROUP 1 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks by age
Within subject coefficient of variation of measures computed by multiparametric renal MRI after 1-2 weeks in healthy volunteers of different age to assess differences in cortical and medullary ADC reproducibility between age classes
Measured: At day 7-14
GROUP 1 - Multiparametric MRI acceptability in healthy volunteers.
Multiparametric MRI acceptability, in terms of comfort level and degree of satisfaction, assessed by a specific 9-item questionnaire ([9-45] range of values, with highest values denoting highest acceptability [Chen S, et al. J Appl Clin Med Phys. 2019; 20(7):184-192]) in healthy volunteers.
Measured: At day 0
GROUP 2 - Multiparametric MRI acceptability in CKD patients.
Multiparametric MRI acceptability, in terms of comfort level and degree of satisfaction, assessed by a specific 9-item questionnaire ([9-45] range of values, with highest values denoting highest acceptability [Chen S, et al. J Appl Clin Med Phys. 2019; 20(7):184-192]) in CKD patients.
Measured: At day 0
GROUP 2 - within subject total kidney volume coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess total kidney volume reproducibility in CKD patients
Measured: At day 7-14
GROUP 2 - within subject renal artery blood flow coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess renal artery blood flow reproducibility in CKD patients
Measured: At day 7-14
GROUP 2 - within subject cortical perfusion coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical perfusion reproducibility in CKD patients
Measured: At day 7-14
GROUP 2 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T1 reproducibility in CKD patients
Measured: At day 7-14
GROUP 2 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T2 reproducibility in CKD patients
Measured: At day 7-14
GROUP 2 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MR repeated after 1-2 weeks to assess cortical and medullary R2* reproducibility in CKD patients
Measured: At day 7-14
GROUP 2 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary ADC reproducibility in CKD patients
Measured: At day 7-14
GROUP 2 - Correlation coefficient between MRI-based parameters and eGFR
Assessment of the correlation coefficient between MRI-based parameters and eGFR to provide preliminary evidence of the nature and degree of change in multiparametric MRI measures across different stages of CKD
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start25 Nov 2022
- Primary completion13 Mar 2025
- Study completionDec 2025 (estimated)
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.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of subjects (healthy volunteers and CKD patients) are involved in the study and will follow separate workflows.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra, Aarhus University Hospital, Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Giuseppe Remuzzi, MD, Study chair, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229263
- Sponsor's protocol ID
- RESPECT
- Acronym
- RESPECT
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2022
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Multicentre Clinical Study to Assess Repeatibility, Reproducibility, Acceptability and Clinical Validity of Multiparametric Renal Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05229263
- Acronym / sponsor ID
- RESPECT / RESPECT
- Conditions
- Chronic Kidney Diseases, Healthy
- Keywords
- Multiparametric MRI, Chronic kidney disease, Standardization, Clinical validity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra, Aarhus University Hospital, Heidelberg University
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Feb 2022 (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.
Chronic kidney disease (CKD) is a global health concern because more than 10% of the world's population have it, its prevalence is increasing, and CKD is an important contributor to morbidity and mortality for this population.
The majority of the people with CKD aren't aware and there are not available tools for early CKD detection and for an accurate prediction on these patients. Many CKD patients exhibit progressive renal dysfunction, demonstrating a failure of current, non-specific therapeutic strategies. Better methods are urgently needed for i) early diagnosis of CKD, and prediction of its progression for improved stratification of patients and better targeting of current treatments; and ii) to directly assess structural and functional responses of the kidney to new therapies and identify those patients who respond.
Over the past decade, renal Magnetic Resonance Imaging (MRI) has emerged as a promising technique for improved understanding and characterisation of renal pathophysiology. Compared to histopathology, MRI is non-invasive and avoids sampling bias by characterising the entire kidney with high spatial resolution.
In spite of a number of single centre studies showing renal MRI feasibility and potential to address a number of key clinical questions, current methodological differences across studies hinder reliable comparisons of the results, which can only be regarded as preliminary. Standardization of acquisition and processing protocols across centres is therefore needed, and this will also lead to the possibility to provide preliminary data of the multiparametric renal MRI clinical validity and utility.
The purpose of this study is to standardize, assess the feasibility and provide preliminary evidence of clinical validity and utility of the multiparametric renal MRI.
To reach this goal two groups of subjects are involved:
- Group 1 (healthy volunteers). In this group the repeatibility and reproducibility of multiparametric renal MRI will be assessed.
- Group 2 (CKD patients). In this group the feasibility, the acceptability, the reproducibility and the preliminary clinical validity of multiparametric renal MRI will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of subjects (healthy volunteers and CKD patients) are involved in the study and will follow separate workflows.
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Diagnostic Test: Non- contrast Enhanced Multiparametric Renal Magnetic Resonance |
| CKD patients | Experimental | Diagnostic Test: Non- contrast Enhanced Multiparametric Renal Magnetic Resonance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of written informed consent prior to any study specific procedures
- Male and female subjects aged more than18 years
- Normotensive (office Systolic Blood Pressure values < 140 mmHg and Diastolic Blood Pressure values ≤ 90 mmHg)
- Normal renal condition for age (established by estimating Glomerular Filtration Rate using CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration, Creatinine Equation)
- Negative result upon urine dipstick testing for haematuria or proteinuria.
Key exclusion criteria (15 listed)
- GROUP 1 and 2
- Previous enrollment in the present study
- Contraindications to MRI including due to:
- Urine Albumin-to-Creatinine Ratio higher than 2000 mg/g or 24h urine total albumin >2 g
- Polycystic kidney disease, renovascular disease, active/current nephrotic syndrome, reflux nephropathy and known congenital renal diseases or solitary kidney.
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 |
|---|---|---|
| Non- contrast Enhanced Multiparametric Renal Magnetic ResonanceMRI is performed in a single multiparametric scan session with no need for contrast agents, and to depict changes in tissue microstructure associated with inflammation and fibrosis plus alterations in oxygenation. | Diagnostic test | CKD patients, Healthy volunteers |
Primary outcome
GROUP 1: within subject total kidney volume coefficient of variation in few hour time
Time frame: At day 0
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess total kidney volume repeatability in the whole group of healthy volunteers
GROUP 1: within subject total kidney volume coefficient of variation after 1-2 weeks
Time frame: At day 7-14
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess total kidney volume reproducibility in the whole group of healthy volunteers
GROUP 1: within subject renal artery blood flow coefficient of variation in few hour time
Time frame: At day 0
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess renal artery blood flow repeatability in the whole group of healthy volunteers
GROUP 1: within subject renal artery blood flow coefficient of variation after 1-2 weeks
Time frame: At day 7-14
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess renal artery blood flow reproducibility in the whole group of healthy volunteers
GROUP 1: within subject cortical perfusion coefficient of variation in few hour time
Time frame: At day 0
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical perfusion repeatability in the whole group of healthy volunteers
GROUP 1: within subject cortical perfusion coefficient of variation after 1-2 weeks
Time frame: At day 7-14
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical perfusion reproducibility in the whole group of healthy volunteers
GROUP 1: within subject cortical and medullary T1 coefficient of variation in few hour time
Time frame: At day 0
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary T1 repeatability in the whole group of healthy volunteers
GROUP 1: within subject cortical and medullary T1 coefficient of variation after 1-2 weeks
Time frame: At day 7-14
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T1 reproducibility in the whole group of healthy volunteers
GROUP 1: within subject cortical and medullary T2 coefficient of variation in few hour time
Time frame: At day 0
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary T2 repeatability in the whole group of healthy volunteers
GROUP 1: within subject cortical and medullary T2 coefficient of variation after 1-2 weeks
Time frame: At day 7-14
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary T2 reproducibility in the whole group of healthy volunteers
GROUP 1: within subject cortical and medullary R2* coefficient of variation in few hour time
Time frame: At day 0
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary R2* repeatability in the whole group of healthy volunteers
GROUP 1: within subject cortical and medullary R2* coefficient of variation after 1-2 weeks
Time frame: At day 7-14
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary R2* reproducibility in the whole group of healthy volunteers
GROUP 1: within subject cortical and medullary ADC coefficient of variation in few hour time
Time frame: At day 0
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated in few hour time to assess cortical and medullary ADC repeatability in the whole group of healthy volunteers
GROUP 1: within subject cortical and medullary ADC coefficient of variation after 1-2 weeks
Time frame: At day 7-14
Within subject coefficient of variation of measures computed by multiparametric renal MRI repeated after 1-2 weeks to assess cortical and medullary ADC reproducibility in the whole group of healthy volunteers
GROUP 2 - Percentage of complete renal MRI data collection and analysis
Time frame: At day 0
Percentage of complete renal MRI data acquired and generated by MRI data processing in the whole group of CKD patients, to assess feasibility of multiparametric renal MRI in CKD patients
38 secondary outcomes
GROUP 1 - within subject renal total kidney volume coefficient of variation in few hour time by gender
Time frame: At day 0
GROUP 1 - within subject renal artery blood flow coefficient of variation in few hour time by gender
Time frame: At day 0
GROUP 1 - within subject cortical perfusion coefficient of variation in few hour time by gender
Time frame: At day 0
GROUP 1 - within subject cortical and medullary T1 coefficient of variation in few hour time by gender
Time frame: At day 0
GROUP 1 - within subject cortical and medullary T2 coefficient of variation in few hour time by gender
Time frame: At day 0
GROUP 1 - within subject cortical and medullary R2* coefficient of variation in few hour time by gender
Time frame: At day 0
GROUP 1 - within subject cortical and medullary ADC coefficient of variation in few hour time by gender
Time frame: At day 0
GROUP 1 - within subject total kidney volume coefficient of variation in few hour time by age
Time frame: At day 0
GROUP 1 - within subject renal artery blood flow coefficient of variation in few hour time by age
Time frame: At day 0
GROUP 1 - within subject cortical perfusion coefficient of variation in few hour time by age
Time frame: At day 0
GROUP 1 - within subject cortical and medullary T1 coefficient of variation in few hour time by age
Time frame: At day 0
GROUP 1 - within subject cortical and medullary T2 coefficient of variation in few hour time by age
Time frame: At day 0
GROUP 1 - within subject cortical and medullary R2* coefficient of variation in few hour time by age
Time frame: At day 0
GROUP 1 - within subject cortical and medullary ADC coefficient of variation in few hour time by age
Time frame: At day 0
GROUP 1 - within subject total kidney volume coefficient of variation after 1-2 weeks by gender
Time frame: At day 7-14
GROUP 1 - within subject renal artery blood flow coefficient of variation after 1-2 weeks by gender
Time frame: At day 7-14
GROUP 1 - within subject cortical perfusion coefficient of variation after 1-2 weeks by gender
Time frame: At day 7-14
GROUP 1 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks by gender
Time frame: At day 7-14
GROUP 1 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks by gender
Time frame: At day 7-14
GROUP 1 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks by gender
Time frame: At day 7-14
GROUP 1 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks by gender
Time frame: At day 7-14
GROUP 1 - within subject total kidney volume coefficient of variation after 1-2 weeks by age
Time frame: At day 7-14
GROUP 1 - within subject renal artery blood flow coefficient of variation after 1-2 weeks by age
Time frame: At day 7-14
GROUP 1 - within subject cortical perfusion coefficient of variation after 1-2 weeks by age
Time frame: At day 7-14
GROUP 1 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks by age
Time frame: At day 7-14
GROUP 1 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks by age
Time frame: At day 7-14
GROUP 1 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks by age
Time frame: At day 7-14
GROUP 1 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks by age
Time frame: At day 7-14
GROUP 1 - Multiparametric MRI acceptability in healthy volunteers.
Time frame: At day 0
GROUP 2 - Multiparametric MRI acceptability in CKD patients.
Time frame: At day 0
GROUP 2 - within subject total kidney volume coefficient of variation after 1-2 weeks
Time frame: At day 7-14
GROUP 2 - within subject renal artery blood flow coefficient of variation after 1-2 weeks
Time frame: At day 7-14
GROUP 2 - within subject cortical perfusion coefficient of variation after 1-2 weeks
Time frame: At day 7-14
GROUP 2 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks
Time frame: At day 7-14
GROUP 2 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks
Time frame: At day 7-14
GROUP 2 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks
Time frame: At day 7-14
GROUP 2 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks
Time frame: At day 7-14
GROUP 2 - Correlation coefficient between MRI-based parameters and eGFR
Time frame: At day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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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.
Giuseppe Remuzzi, MD study chair
Istituto Di Ricerche Farmacologiche Mario Negri
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non- contrast Enhanced Multiparametric Renal Magnetic Resonance in people with Chronic Kidney Diseases and Healthy, run by Mario Negri Institute for Pharmacological Research at 4 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 11 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Germany, Italy, 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?
This study is still under way. Results are not available in the source record yet.
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?
GROUP 1: within subject total kidney volume coefficient of variation in few hour time (time frame: At day 0). The study lists 15 primary outcomes in all. 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 26 Mar 2025.