Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
184
Countries
1
Sites
3
Kidney transplant recipients
Determine the effect of oral SGLT2i compared with placebo as add-on to standard-of-care on PTDM incidence in non-diabetic KTR.
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
- Decision date (initial)
- 2026-03-09
- 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: Therapy
Determine the effect of oral SGLT2i compared with placebo as add-on to standard-of-care on PTDM incidence in non-diabetic KTR.
Secondary objectives 1
- To evaluate the effect of oral SGLT2i compared with placebo, as an add-on to standard-of-care, in non-diabetic kidney transplant recipients (KTR), with respect to: • Prediabetes status • Urinary albumin-to-creatinine ratio (U-ACR) • Incidence of urinary tract infections • Renal function parameters • Cardiovascular parameters • Adverse events
Conditions and MedDRA coding
Kidney transplant recipients
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | From first participant first visit (FPFV) to last participant last visit (LPLV) This is a multicentre, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of an SGLT2 inhibitor compared with placebo in newly kidney transplant recipients. A total of 184 adult participants will be enrolled and randomized in a 1:1 ratio to receive either the SGLT2 inhibitor or matching placebo, in addition to standard post-transplant care. Participants will be followed for 12 months after randomization. Study assessments are conducted in connection with routine post-transplant clinical visits, and all study data are recorded in the electronic case report form (eCRF).
|
Randomised Controlled | Double | [{"id":173466,"code":2,"name":"Investigator"},{"id":173464,"code":1,"name":"Subject"},{"id":173462,"code":5,"name":"Carer"},{"id":173463,"code":4,"name":"Analyst"},{"id":173465,"code":3,"name":"Monitor"}] | Experimental arm (SGLT2 inhibitor): A total of 92 newly kidney transplant recipients will be randomized and allocated to receive treatment with an SGLT2 inhibitor for a duration of 12 months, in addition to standard post-transplant care. Control arm (Placebo): A total of 92 newly kidney transplant recipients will be randomized and allocated to receive matching placebo for a duration of 12 months, in addition to standard post-transplant care. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- • Obtained written informed consent
- • Male or female patients, age ≥ 18 years.
- • Non-diabetic Kidney Transplant Recipient
- • eGFR> 25 ml/min/1.73m2 within the last 3 months pre randomization
- • Immunosuppressive must include Tacrolimus
Exclusion criteria 9
- • Patients who is 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
- • Positive plasma hCG
- • Breastfeeding
- • Known allergy towards SGLT2i or the content substance
- • Patients with chronic intestinal diseases, including inflammatory bowel diseases (e.g., Crohn’s disease and ulcerative colitis) and structural conditions such as short bowel syndrome.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • Post Transpalnt Diabetes Mellitus incidence after 6 and 12 months follow-up
Secondary endpoints 16
- Prediabetes incidence after 6 and 12 month follow-up
- eGFR change after 6 and 12 month follow up.
- Proteinuria determined by Albumin/creatinine ratio (U-ACR) (mg/g)
- Change in creatinine and Cholesterol after 6 and 12 month follow-up
- Incidence og urinaty tract infection determined by (positive urine culture)
- Incidence of kidney transplant rejection (biopsy verified)
- Renal composite outcome o Incidence of graft failure (defined as return to dialysis or retransplantation) o Incidence of ESRD (defined as eGFR<15 ml/min/1.73m2) o 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
- Incidence of Serious adverse events
- Incidence of serious adverse reactions
- Incidence of death (all cause mortality)
- Incidence of Major Adverse Cardiac Events (MACE)
- Change in score for Short Form Health Survey 36 between baseline and after 12 month follow-up
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 USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3650 mg milligram(s)
- Max treatment duration
- 12 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
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3650 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- 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
- Lotte Borg Lange
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Lotte Borg Lange
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 184 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Odense University Hospital
Dept. Nephrology, J. B. Winsloews Vej 4, 5000, Odense C
Aarhus Universitet
Dept. Nephrology, Palle Juul-Jensens Boulevard 82, 8200, Aarhus N
Copenhagen University Hospital
Dept. Nephrology, Blegdamsvej 9, 2100, Copenhagen Oe
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 2024-518774-14-00 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_Participant infromation brochure | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults track of change | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults urine sampling OUH | 2 |
| 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) | Track of change L1_SIS and ICF adults urine sampling OUH | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E_ SmPC Forxiga | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis EU CT 2024-518774-14-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-18 | Denmark | Acceptable 2026-03-06
|
2026-03-09 |