Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
8
Countries
1
Sites
1
Kidney transplant recipients
To evaluate the acute effect of SGLT2i on kidney allograft oxygen tension in cortex and medulla.
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 27 Mar 2025 → 9 Sep 2025
- Decision date (initial)
- 2025-01-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Nefrologisk afd. OUH · Region Syddanmark · Vissing Fonden · Dansk Nefrologisk Selskab · Steno Diabetes Center Odense
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic
To evaluate the acute effect of SGLT2i on kidney allograft oxygen tension in cortex and medulla.
Secondary objectives 1
- To evaluate the acute effect of SGLT2i on kidney allograft perfusion, renal artery blood flow, blood pressure, heartrate and glucose excretion.
Conditions and MedDRA coding
Kidney transplant recipients
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10023438 | Kidney transplant | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- - Written informed consent must be provided before participation
- - Male or female patients ≥ 18 years of age
- - Non-diabetic kidney transplant recipients, > 6 months post-transplant
- - Stable eGFR> 20 ml/min (stable defined as eGFR 20 ml/min ± 5 ml/min variation in the last 3 months)
- - Tacrolimus(Adport) and Mycophenolatmofetile (Myfenax, cellcept) as part of immunosuppressive treatment
Exclusion criteria 8
- - Diabetic kidney disease type 1 or 2 (World Health Organization (WHO) criteria)
- - Renal allograft failure (eGFR< 20 ml/min)
- - Alanine aminotransferase (ALAT) > 3 x upper normal limit or bilirubin > 2 x upper normal limit
- - Pregnancy or breastfeeding
- - Exclusion criteria for MRI o Claustrophobia/physical not able to lie in MR-scanner for 2 hours o MRI safety hazards such as cardiac pacemaker, implantable cardioverter defibrillator (ICD), non-MRI compatible implants and implanted devices, intraorbital or intracranial metallic foreign bodies.
- - Allergy towards SGLT2i or the content substance
- - Known intestinal bowel disease
- - Prednisone treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • Kidney allograft cortical and medullary oxygen tension, estimated by BOLD-MRI based renal T2* relaxation rate.
Secondary endpoints 5
- • Renal cortical and medullary perfusion ml/100 g/min
- • Renal artery blood flow ml/min
- • Blood glucose mmol/L
- • Systolic blood pressure (SysBP) and diastolic blood pressure (DiaBP) mmHg
- • Heart rate (HR), beats min-1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Jardiance 25 mg film-coated tablets
PRD1594891 · Product
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10BK03 — -
- Marketing authorisation
- EU/1/14/930/001
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo with no active substance and produces by the hospital pharmacy
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Claus Bistrup
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Claus Bistrup
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 8 | 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 | 2025-03-27 | 2025-09-09 | 2025-03-27 | 2025-06-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| SGL-TX-MR summary of results SUM-104123
|
2025-10-29T15:26:35 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay Person Summary of Results | 2025-10-29T15:32:28 | Submitted | Laypersons Summary of Results |
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 19-4 Lay person summary of results | 1 |
| Protocol (for publication) | D1_ Protocol EU CT 2024-513765-40-00 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_ Participant information brochure | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information - Dine rettigheder som forsgsperson i forsg med medicin | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material - Participant Information Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material - Dataprotection | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Jardiance | 1 |
| Summary of results (for publication) | 19-3 SGL TX MR Summary of results | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ENG EU CT 2024-513765-40-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-31 | Denmark | Acceptable 2025-01-13
|
2025-01-21 |