What is dapagliflozin studying for kidney transplant patients?

Dapagliflozin is being studied to see if it can help preserve kidney filtration function, reduce tissue scarring, and improve metabolic risk factors in people who have recently had a kidney transplant. The research aims to understand these effects compared to a placebo over three years. This trial is led by Oslo University Hospital to improve outcomes for kidney transplant recipients.

Who may be eligible for this kidney transplant clinical trial?

Adults aged 18 to 75 who have received a kidney transplant about 6 weeks ago at Oslo University Hospital may be eligible. Participants must be able to manage their medical treatments and have stable kidney function with an estimated GFR of 25 or higher. People with type 1 diabetes, recent rejection episodes, or current infections are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this kidney transplant clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs associated with study visits.

Actively Recruiting

Phase 4

Age: 18Years - 75Years

All Genders

ID05788276

Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

Led by Oslo University Hospital · Updated on 2025-04-01

330

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of SGLT2 inhibition in patients who received a kidney transplant 6 weeks earlier at Oslo University Hospital. The study aims to determine if dapagliflozin can help preserve kidney filtration function, reduce kidney tissue scarring, and improve metabolic risk factors like obesity, glucose intolerance, and high blood pressure that could lead to graft failure. This is a randomized, placebo-controlled trial involving 330 participants. Participants are randomly assigned to receive either dapagliflozin 10 mg or a placebo once daily, starting 6 weeks after transplantation. The study lasts for 150 weeks (about 3 years), with detailed assessments before treatment and at several points during follow-up. Investigations include kidney biopsies, measured and estimated glomerular filtration rate (GFR), blood pressure, oral glucose tolerance tests, body composition scans (DXA), and urine protein measurements. Molecular analyses of kidney tissue samples will also be conducted in a subgroup. Throughout the trial, participants will undergo repeated blood tests, blood pressure monitoring, and kidney function evaluations at multiple timepoints, including weeks 2, 8, 72, 78, and 150 after randomization. The study will monitor kidney function changes over time, kidney tissue fibrosis, metabolic changes, and safety. After the study, participants may continue treatment with SGLT2 inhibitors if deemed appropriate by their doctors, and long-term outcomes like graft loss and cardiovascular events will be tracked up to 10 years post-transplantation.