Chronic kidney disease and polycystic kidney disease MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Name: Hyperpolarized [1-13C]pyruvate
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
INN or Proposed INN: SODIUM PYRUVATE
Other descriptive name: SODIUM
Sponsors
Aarhus University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the metabolic signature of CKD and PDK using multi-parametric MR including hyperpolarized pyruvate. ;Secondary Objective: Not applicable;Primary end point(s): Kidney metabolism as assessed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine.;Timepoint(s) of evaluation of this end point: After imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease characterization from clinical examination, interviews, patient records, and renography.;Timepoint(s) of evaluation of this end point: Before the MRI | — |
Countries
Denmark
Contacts
Public ContactThe MR Research Center
Aarhus University
Outcome results
None listed