Actively Recruiting
Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
Led by Oslo University Hospital · Updated on 2025-04-01
330
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
S
St. Olavs Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Renal transplant recipients transplanted 6 weeks earlier at Oslo University Hospital Rikshospitalet
- Age 18-75 years
- Able to comply with the medical treatment on their own
- Calcineurin inhibitor trough concentrations within individual therapeutic range and standard dose prednisolone and mycophenolate mofetil over the last 2 weeks
- Estimated GFR 6525 mL/min/1.73 m2
You will not qualify if you...
- 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
- Known hypersensitivity to dapagliflozin or any excipients of the product
- For women only - currently pregnant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Oslo, Norway, 0372
Actively Recruiting
Research Team
T
Trond Geir Jenssen, MD
CONTACT
C
Charlotte Kongerud, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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