Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Trond Geir Jenssen, MD
tjenssen@ous-hf.no
0047 23073646
Backup
Charlotte Kongerud, MD
ingkon@ous-hf.no
004723071917
Time Frame
Start Date: 2023-05-02
Estimated Completion Date: 2028-06
Participants
Target number of participants: 330
Treatments
Active_comparator: Active treatment
165 patients
Placebo_comparator: Control group
165 patients
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital of North Norway, St. Olavs Hospital, Haukeland University Hospital
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov