Status:
ACTIVE_NOT_RECRUITING
Multiparametric MRI in Healthy Volunteers and CKD Patients
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
Clinica Universidad de Navarra, Universidad de Navarra
Aarhus University Hospital
Conditions:
Chronic Kidney Diseases
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
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 mort...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
November 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05229263
Start Date
November 25 2022
End Date
December 1 2025
Last Update
March 26 2025
Active Locations (4)
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1
Aarhus University Hospital, Department of Renal Medicine
Århus N, Århus N, Denmark, 8200
2
University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University
Heidelberg, Mannheim, Germany
3
Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"
Ranica, BG, Italy, 24020
4
Clínica Universidad de Navarra
Pamplona, Navarre, Spain, 31008