Chronic kidney disease – imaging the metabolic derangements with ultra-sensitive MRI

Phase 1

Conditions: Chronic kidney disease and polycystic kidney disease
MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominantSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Registration Number: EUCTR2021-002551-11-DK

Lead Sponsor: Aarhus University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

•All participants:
-Aged 18 – 85 years.
-Pre-menopausal women must be confirmed non-pregnant by an onsite test.
•PKD group:
-Autosomal dominant polycystic kidney disease.
•CKD group
-CKD for any reason except PKD.
-Recent biopsy (within 3 months of MRI).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

•Contraindications for MRI with contrast:
-eGFR less than 30 ml/min/1.73m2
-Significant cardiac disease such as severe left ventricular outflow obstruction
-Significant obstructive lung disease or severe asthma
-Pacemaker, neurostimulator or cholera implant
-Metal foreign bodies such as fragments and irremovable piercings
-Unsafe medical implants (safety of heart valves, hips and the like must be confirmed)
-Claustrophobia
-Largest circumference including arms > 160 cm
•Competing renal or systemic disease (except unspecific renal MRI findings, hypertension, atherosclerosis, well-regulated diabetes and hyperlipidemia/cholesterolemia which are allowed)
•Renovascular disease
•Allergy to pyruvate