Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
88
Countries
1
Sites
4
Kidney transplant recipients
In this non-inferior randomized controlled clinical trial we determine the safety and efficacy of oral SGLT2i compared with placebo as add-on to standard-of-care on affecting kidney transplant function (eGFR) in non-diabetic kidney transplant recipients.
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
- 12 Aug 2025 → ongoing
- Decision date (initial)
- 2025-06-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- DKK 610,000: Region of Southern Denmark PhD grant · DKK 610,000: Steno Diabetes Center Odense PhD grant · DKK 730,000: Department of Nephrology, OUH · DKK 9,500: Danish Society of Nephrology Travel Fund · DKK 1,978,000: Karen Elise Jensen’s Foundation · DKK 50,000: The Danish Kidney Association Research Fund · DKK 60,000: Danish Society of Nephrology · DKK 628,000: Odense University Hospital (OUH) PhD grant · DKK 695,000: Vissing Foundation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
In this non-inferior randomized controlled clinical trial we determine the safety and efficacy of oral SGLT2i compared with placebo as add-on to standard-of-care on affecting kidney transplant function (eGFR) in non-diabetic kidney transplant recipients.
Secondary objectives 2
- The secondary objectives will evaluate the effect of oral SGLT2i compared with placebo as add-on to standard-of-care on urinary tract infection, incidence of Post Transplant Diabetes Mellitus and prediabetes status, Urine-Aalbumin Creatinine Ratio, renal parameters, cardiovascular parameters and adverse events in non-diabetic kidney transplant recipients.
- The tertiary objective is to examine the SGLT2i effect on overall health by using the validated SF-36 survey.
Conditions and MedDRA coding
Kidney transplant recipients
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10023438 | Kidney transplant | 10042613 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | SGL-TX-GFR: From start of study until end of study. The trial include a total of 88 non-diabetic KTR.
44 patients will be randomly assigned to treatment with SGLT2i after inclusion, follow up for 18 months.
44 patients will be randomly assigned to treatment with placebo after inclusion, follow up for 18 months.
|
Randomised Controlled | Double | [{"id":126120,"code":3,"name":"Monitor"},{"id":126122,"code":1,"name":"Subject"},{"id":126119,"code":4,"name":"Analyst"},{"id":126121,"code":2,"name":"Investigator"}] | Intervention arm: 44 patients will be randomly assigned to treatment with SGLT2i after inclusion, follow up for 18 months. Placebo arm: 44 patients will be randomly assigned to treatment with placebo after inclusion, follow up for 18 months. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Obtained written informed consent
- Male or female patients, age ≥ 18 years
- Non-diabetic Kidney Transplant Recipient
- > 6 months post-transplant
- eGFR> 25 ml/min/1.73m2 within the last 3 months pre randomization
- Immunosuppressive must include Tacrolimus
- Negative plasma hCG in fertile women, and acceptance of the use of contraception during the course of the study.
Exclusion criteria 8
- Patients treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization
- eGFR< 25 ml/min/1.73m2 (before randomization)
- Alanine aminotransferase (ALAT) > 3 x upper normal limit
- Bilirubin > 2 x upper normal limit
- Pregnancy
- Breastfeeding
- Known allergy towards SGLT2i or the content substance
- Known intestinal bowel disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Chronic eGFR slope (ml/min/1.73m2) measured from week 4, and then every 3 month until 18 month post randomization.
Secondary endpoints 18
- Albumin/creatinine ratio (U-ACR) (mg/g)
- Creatinine (umol/L)
- Total-Cholesterol
- Low-and high-density lipoproteins (LDL and HDL)
- Triglycerides
- Clinical routine Tacrolimus concentration (ug/L)
- ALAT (U/L)
- Bilirubin
- Pro-BNP, renin, angiotensin-2, aldosterone
- Frequence of positive urine cultures
- Incidence of Post Transplant Diabetes Mellitus and prediabetes status
- Change in volume status in week 1 of therapy (Weight)
- Incidence of kidney transplant rejection (biopsy verified)
- Renal composite outcome (Incidence of graft failure (defined as return to dialysis or retransplantation), Incidence of ESRD (defined as eGFR<15 ml/min/1.73m2), Incidence of > 25% increase in creatinine
- Change in Systolic blood pressure (SysBP) (mmHg) and diastolic blood pressure (DiaBP) (mmHg)
- Relative incidence of out-of-target measures of clinical routine blood Tacrolimus levels
- Urine biomarkers indicative of podocyt and tubular function from selected sites
- Incidence of: Adverse events, Serious adverse events, Serious adverse reactions, Death – all cause mortality, Major Adverse Cardiac Events (MACE)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Forxiga 10 mg film-coated tablets
PRD2427550 · Product
- Active substance
- Dapagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 5400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — -
- Marketing authorisation
- EU/1/12/795/009
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
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
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Claus
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 88 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Aarhus Universitet
Dept. Nephrology, Palle Juul-Jensens Boulevard 82, 8200, Aarhus N
Rigshospitalet
Dept. Nephrology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Midtjylland
Dept. Nephrology, Hospitalsparken 15, 7400, Herning
Odense University Hospital
Dept. Nephrology, J. B. Winsloews Vej 4, 5000, Odense C
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 | 2025-08-12 | 2025-10-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2024-518773-33-00 | 2 |
| Protocol (for publication) | SF36 questionnaire | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3 |
| Recruitment arrangements (for publication) | K2_Participant information brochure | 1 |
| Recruitment arrangements (for publication) | Recruitment letter for e-boks | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| Subject information and informed consent form (for publication) | L2_ Other subject information - Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information - Dataprotection | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material - Participant Information Card | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Forxiga | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG EU CT 2024-518773-33-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-21 | Denmark | Acceptable 2025-06-03
|
2025-06-20 |