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Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

Study acronym: DEAKTransplant
StatusRecruiting
PhasePhase 4
Started2023-05-02
View on ClinicalTrials.gov ↗

Amendment history

2025-03-26
Study Identification, Study Status, Eligibility, Contacts/Locations v2
Primary completion date2025-03→2028-06
Eligibility criteria-23 characters
[...] eeks. Estimated GFR ≥25 mL/min/1.73 m2. Exclusion Criteria: Repeat transplantation Type 1 diabetes Rejection episodes of the kidney graft prior [...]
Study sitesdetails revised at 1 of 1 site
2023-05-07
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-03→confirmed 2023-05-02
Study sites0→1
2023-03-27
Original filing
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.
Trial Details
NCT Number NCT05788276
Lead Sponsor Oslo University Hospital
Collaborators: St. Olavs Hospital, University Hospital of North Norway, Haukeland University Hospital
Conditions Kidney Transplant; Complications, Kidney Transplant Failure, Renal Failure
Enrollment 330 participants
Start Date 2023-05-02
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2025-04-01