MedTrace Logo

Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

NCT05788276 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

  • Kidney Transplant; Complications
  • Kidney Transplant Failure
  • Renal Failure

Interventions

DRUG

Dapagliflozin 10mg Tab

Dapagliflozin active tablets

DRUG

Placebo

Matched placebo tablets

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Trond Geir Jenssen, MD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05788276 on ClinicalTrials.gov