Multiparametric MRI in Healthy Volunteers and CKD Patients

NCT ID: NCT05229263

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-25
• Study Completion Date: 2025-12-31

Brief 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.

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.

Conditions

Chronic Kidney Diseases; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Group Type: EXPERIMENTAL

Non- contrast Enhanced Multiparametric Renal Magnetic Resonance

Intervention Type: DIAGNOSTIC_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.

CKD patients

Group Type: EXPERIMENTAL

Non- contrast Enhanced Multiparametric Renal Magnetic Resonance

Intervention Type: DIAGNOSTIC_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.

Interventions

Non- contrast Enhanced Multiparametric Renal Magnetic Resonance

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

GROUP 1:

1. Provision of written informed consent prior to any study specific procedures

2. Male and female subjects aged more than18 years

3. Normotensive (office Systolic Blood Pressure values < 140 mmHg and Diastolic Blood Pressure values ≤ 90 mmHg)

4. Normal renal condition for age (established by estimating Glomerular Filtration Rate using CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration, Creatinine Equation)

5. Negative result upon urine dipstick testing for haematuria or proteinuria.

6. Normal Urine Albumin-to-Creatinine Ratio (UACR) (<30 mg/g)

GROUP 2:

1. Provision of written informed consent prior to any study specific procedures

2. Male and female patients aged more than18 years

3. CKD stage 2 or 3, with albuminuria up to 2000 mg

Exclusion Criteria

GROUP 1 and 2

1. Previous enrollment in the present study

2. Contraindications to MRI including due to:

• Claustrophobia
• Pregnancy
• Cardiac pacemakers or other MRI-incompatible prostheses

Only GROUP 2:

1. Urine Albumin-to-Creatinine Ratio higher than 2000 mg/g or 24h urine total albumin >2 g

2. Polycystic kidney disease, renovascular disease, active/current nephrotic syndrome, reflux nephropathy and known congenital renal diseases or solitary kidney.

3. Active malignancy or acute or chronic inflammatory disease, HIV

4. Acute kidney injury, as defined by the the KDIGO guidelines, during the last three months.

5. Need of a new immunosuppressive therapy for treating renal disease relapse in the preceding three months.

6. Dialysis or kidney transplantation

7. CKD stages 4 or 5

8. New medication in the preceding two weeks (diuretic, hypertensive, SGLT2 treatment)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Remuzzi, MD

Role: STUDY_CHAIR

Istituto Di Ricerche Farmacologiche Mario Negri

Locations

Aarhus University Hospital, Department of Renal Medicine

Århus N, Århus N, Denmark

University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University

Heidelberg, Mannheim, Germany

Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"

Ranica, BG, Italy

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Countries

Denmark; Germany; Italy; Spain

Other Identifiers

RESPECT

Identifier Type: -

Identifier Source: org_study_id