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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aarhus Universitet

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

1 Apr 2024 → ongoing

Decision date (initial)

2024-06-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512491-35-00

EudraCT number

2021-002551-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Others

In this study, we aim to assess the metabolic signature of CKD and PDK using multi-parametric MRI. The study will include healthy volunteers (N=8), CKD patients (N=12), PKD patients (N=10).
PDK patients:
a. The metabolic shift towards glycolysis compared with healthy kidneys can be detected using MRI with hyperpolarized pyruvate.

CKD patients
a. Multi-parametric MRI combined with hyperpolarized pyruvate MRI can detect the metabolic alterations, including upregulated lactate and alanine production, associated with CKD.
b. These alterations correlate with measures of fibrosis and inflammation from biopsies

Secondary objectives 1

1. We aim to examine whether expired CO2 measures improve the clinical utility of hyperpolarized [1-13C]pyruvate MRI

Conditions and MedDRA coding

cronic kidney disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Aged 18 – 85 years (all participants)
2. Pre-menopausal women must be confirmed non-pregnant by an onsite test. (All female participants)
3. Autosomal dominant polycystic kidney disease. (PKD group)
4. CKD for any reason except PKD. (CKD group)
5. Recent biopsy (within 6 months of MRI). (CKD group)
6. eGFR > 60 (PKD patients)

Exclusion criteria 4

1. Contraindications for MRI: - 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
2. Competing renal or systemic disease (except unspecific renal MRI findings, hypertension, atherosclerosis, well-regulated diabetes and hyperlipidemia/cholesterolemia which are allowed)
3. Renovascular disease
4. Allergy to pyruvate

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. MRI signature of the kidney

Secondary endpoints 2

1. Measures of kidney function in blood and urine.
2. Expired CO2 measures

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aarhus Universitet

Sponsor organisation

Aarhus Universitet

Address

Palle Juul-Jensens Boulevard 82

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Aarhus Universitet

Contact name

Malene Aastrup

Public contact point

Organisation

Aarhus Universitet

Contact name

Malene Aastrup

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications