Using Dapagliflozin to Protect Kidney Function After Transplant
Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
PHASE4 · Oslo University Hospital · NCT05788276
This study is testing if the medication dapagliflozin can help protect kidney function in people who had a kidney transplant six weeks ago.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 1 site (Oslo, Oslo) |
| Trial ID | NCT05788276 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dapagliflozin, an SGLT2 inhibitor, on kidney transplant recipients who received their transplant six weeks prior. The study aims to determine if dapagliflozin can preserve glomerular filtration rate (GFR), reduce kidney fibrosis, and improve metabolic risk factors associated with graft failure. Participants will be randomly assigned to receive either dapagliflozin or a placebo for a total of 150 weeks, with various assessments including kidney biopsies and metabolic tests conducted throughout the study. The trial will involve 330 participants at Oslo University Hospital and other collaborating institutions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have received a kidney transplant at Oslo University Hospital six weeks prior and have an estimated GFR of at least 25 mL/min/1.73 m2.
Not a fit: Patients with type 1 diabetes, recent kidney graft rejection, or ongoing infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance kidney function and longevity in transplant recipients, potentially reducing the risk of graft failure.
How similar studies have performed: While the use of SGLT2 inhibitors in kidney transplant patients is a relatively novel approach, preliminary studies suggest potential benefits, indicating that this trial could contribute valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo, Oslo
- Oslo University Hospital — Oslo, Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Trond Geir Jenssen, MD — Oslo University Hospital
- Study coordinator: Trond Geir Jenssen, MD
- Email: tjenssen@ous-hf.no
- Phone: 0047 23073646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Transplant, Complications, Kidney Transplant Failure, Renal Failure, Kidney, Transplantation, SGLT2, Renal function