NCT05229263Active, not recruiting
Multiparametric MRI in Healthy Volunteers and CKD Patients
Exploratory Multicentre Clinical Study to Assess Repeatibility, Reproducibility, Acceptability and Clinical Validity of Multiparametric Renal Magnetic Resonance Imaging
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 14 Jan 2022
- Start date
- 25 Nov 2022
- Primary completion date
- 13 Mar 2025
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Diseases
- Chronic kidney disease
- NCT number
- NCT05229263
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 25 Nov 2022 to the primary completion date, 13 Mar 2025
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous enrollment in the present study
- Dialysis or kidney transplantation
- New medication in the preceding two weeks (diuretic, hypertensive, SGLT2 treatment)
Other illness
- Contraindications to MRI including due to:
- Claustrophobia
- Pregnancy
- Cardiac pacemakers or other MRI-incompatible prostheses
- Only GROUP 2:
- 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
- Need of a new immunosuppressive therapy for treating renal disease relapse in the preceding three months.
Lab values
- Urine Albumin-to-Creatinine Ratio higher than 2000 mg/g or 24h urine total albumin \>2 g
Other
- GROUP 1 and 2
- Acute kidney injury, as defined by the the KDIGO guidelines, during the last three months.
- CKD stages 4 or 5
Who the study is looking for
- 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.
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Aarhus University Hospital, Department of Renal Medicine Coordinator of this site? Confirm its status | Århus N | Denmark | Unknown status |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò" Coordinator of this site? Confirm its status | Ranica | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.