NCT05788276 Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
| NCT ID | NCT05788276 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Oslo University Hospital |
| Condition | Kidney Transplant; Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 330 participants in total. It began in 2023-05-02 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to look at the effect of SGLT2 (Sodium glucose transporter 2) inhibition in patients receiving a kidney-transplant 6 weeks earlier at Oslo University hospital. Rikshospitalet. Investigators will search for answers along three pathways: Can SGLT2 inhibitor 1) preserve glomerular filtration rate (GFR), 2) reduce interstitial fibrosis in the kidney, and 3) favorably improve metabolic risk factors for graft failure such as visceral obesity, glucose intolerance and high blood pressure? The participants (N=330) will be randomized to either dapagliflozin 10 mg or placebo o.d. in a blinded fashion. Researchers will than use kidney transplant biopsies, measured GFR, blood pressure sampling, glucose tolerance test (OGTT), dual-energy X-ray absorptiometry (DXA scan) and estimated GFR from the two groups in comparison, to evaluate the effect treatment. The participants will be followed for a total of 3 years.
Eligibility Criteria
Inclusion Criteria: * Renal transplant recipients transplanted 6 weeks earlier at Oslo University hospital (OUH) Rikshospitalet. * Age 18-75 years. * Able to comply with the medical treatment on their own. * Calcineurin inhibitor trough concentrations in accordance with individual therapeutic range and standard dose prednisolone and mycophenolate mofetil over the last 2 weeks. * Estimated GFR ≥25 mL/min/1.73 m2. Exclusion Criteria: * Type 1 diabetes * Rejection episodes of the kidney graft prior to randomization. * Ongoing infectious disease or intermittent causes affecting renal function, e.g., obstructive lymphocele. * Malnutrition. * Urosepsis less than 1 year prior to randomization. * Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product. * For women only - currently pregnant
Contact & Investigator
Trond Geir Jenssen, MD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT05788276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Kidney Transplant; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05788276 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05788276 currently recruiting?
Yes, NCT05788276 is actively recruiting participants. Contact the research team at tjenssen@ous-hf.no for enrollment information.
Where is the NCT05788276 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT05788276 clinical trial?
NCT05788276 is sponsored by Oslo University Hospital. The principal investigator is Trond Geir Jenssen, MD at Oslo University Hospital. The trial plans to enroll 330 participants.
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