Renal Failure Clinical Trial
Official title:
Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
NCT number | NCT05788276 |
Other study ID # | 2022/426076 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2, 2023 |
Est. completion date | June 2028 |
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.
Status | Recruiting |
Enrollment | 330 |
Est. completion date | June 2028 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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: - Repeat transplantation - 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of Dapagliflozin on the GFR slope in renal transplant patients (Main study) | 1. Difference in eGFR slope between groups. | From before randomization to 3 years after transplantation. | |
Secondary | The effect of Dapagliflozin on renal and metabolic conditions between groups (Main study) | Change in measured GFR (iohexol serum clearance)
Change in mean arterial blood pressure in mmHg Change of DXA-measured visceral fat (grams) Change in hematocrit (%) Change in two hour blood glucose measured by an oral glucose tolerance test in patients without diabetes (mmol/L). Change in urine protein/creatinine ratio (mg/mmol) |
From before randomization to 3 years after transplantation | |
Secondary | Changes in renal graft fibrosis and proteomic markers with SGLT2 inhibition between groups (Sub-study - the 140 first included patients). | Change in inflammation score
Change in fibrosis score Change in kidney graft mRNA score Change in proteomic score |
From before randomization to 3 years after transplantation |
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