Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
27
Countries
1
Sites
1
Diabetic Kidney Disease
We hypothesise that classification of diabetic kidney disease progression is possible with the application of quantitative hyperpolarised [1-13C]pyruvate MRI.
Key facts
- Sponsor
- Aarhus Universitet
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 24 Sep 2024 → ongoing
- Decision date (initial)
- 2024-02-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Safety
We hypothesise that classification of diabetic kidney disease progression is possible with the application of quantitative hyperpolarised [1-13C]pyruvate MRI.
Secondary objectives 4
- Hyperpolarized [1-13C]pyruvate MRI is reproducible as evaluated in healthy subjects.
- Expired CO2 measures improve the clinical utility of hyperpolarized [1-13C]pyruvate MRI.
- Assessment of metabolism and perfusion with hyperpolarized [1-13C]pyruvate MRI correlates with renal function in humans.
- Quantitative hyperpolarized [1-13C]pyruvate perfusion correlates to the gold standard of water PET perfusion.
Conditions and MedDRA coding
Diabetic Kidney Disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- All participants: Aged 18 – 85 years and pre-menopausal women must be confirmed non-pregnant.
- Type 1 Diabetes Mellitus with diabetic kidney disease: eGFR > 15ml/min and eGFR=< 60 ml/min and urine albumin-creatinine ratio > 100 mg/g)
- Type 1 diabetes mellitus without diabetic kidney disease: eGFR > 60 ml/min and no albuminuria (urine albumin-creatinine ratio < 30 mg/g) and No signs of proliferative retinopathy or macular edema.
- Control Subjects must have eGFR>60
Exclusion criteria 4
- Contraindications for MRI: Significant cardiac disease, Obstructive lung disease, pacemaker, neurostimulator, cholera implant, metal foreign bodies, claustrophobia, largest circumference including arms > 160 cm.
- Competing systemic diseases
- Stents or other devices implanted close to the kidneys that may cause imaging artifacts
- Pyruvate Allergy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Metabolism and perfusion of kidney by hyperpolarised pyruvate
Secondary endpoints 2
- Glomerular Filtration Rate (Renography)
- reproducibility of hyperpolarised pyruvate MRI
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hyperpolarized [1-13C]pyruvate
PRD10284730 · Product
- Active substance
- Pyruvic Acid
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0.43 millilitre(s)/kilogram
- Max total dose
- 0.43 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
SCP11412561 · ATC
- Active substance
- Meglumine Gadoterate
- Substance synonyms
- Gadoterate meglumine
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0.10 mmol/kg millimole(s)/kilogram
- Max total dose
- 0.10 mmol/kg millimole(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08CA02 — GADOTERIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- Charlotte Brinck Holt
Public contact point
- Organisation
- Aarhus Universitet
- Contact name
- Charlotte Brinck Holt
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 27 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-09-24 | 2024-11-12 | 2026-05-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 protocol TrackChange | 4 |
| Protocol (for publication) | D1_Protocol 2023-508824-36-00 | 4 |
| Recruitment arrangements (for publication) | Advertisement | 3 |
| Recruitment arrangements (for publication) | Advertisement Diabetesforeningen RFI | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Track change SM01 | 2 |
| Subject information and informed consent form (for publication) | Deltagerinformation Control Subjects_version 4 trackchange | 2 |
| Subject information and informed consent form (for publication) | Deltagerinformation Type 1 Diabetes _version 4 trackchange | 1 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF description 2023-508824-36-00 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS control subjects | 2 |
| Subject information and informed consent form (for publication) | L1_SIS Type 1 Diabetes | 2 |
| Synopsis of the protocol (for publication) | D1_ protocol synopsis 2023-508824-36-00 | 2 |
| Synopsis of the protocol (for publication) | D1_ protocol synopsis TC 2023-508824-36-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-06 | Denmark | Acceptable 2024-02-28
|
2024-02-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-11 | Denmark | Acceptable 2025-02-12
|
2025-02-12 |