Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOslo University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dapagliflozin 10mg Tab
DrugDapagliflozin active tablets
Placebo
DrugMatched placebo tablets
Treatment groups
330 Participants
are divided into 2 treatment groupsGroup A: Active treatmentActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Effect of Dapagliflozin on the GFR slope in renal transplant patients (Main study)
1\. Difference in eGFR slope between groups.
Time frame
From before randomization to 3 years after transplantation.Secondary outcomes
1
The effect of Dapagliflozin on renal and metabolic conditions between groups (Main study)
1. Change in measured GFR (iohexol serum clearance) 2. Change in mean arterial blood pressure in mmHg 3. Change of DXA-measured visceral fat (grams) 4. Change in hematocrit (%) 5. Change in two hour blood glucose measured by an oral glucose tolerance test in patients without diabetes (mmol/L). 6. Change in urine protein/creatinine ratio (mg/mmol)
Time frame
From before randomization to 3 years after transplantation2
Changes in renal graft fibrosis and proteomic markers with SGLT2 inhibition between groups (Sub-study - the 140 first included patients).
1. Change in inflammation score 2. Change in fibrosis score 3. Change in kidney graft mRNA score 4. Change in proteomic score
Time frame
From before randomization to 3 years after transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
St. Olavs Hospital
Collaborator
University Hospital of North Norway
Collaborator
Haukeland University Hospital
Collaborator
Source ClinicalTrials.gov