AuthorisedTherapeutic exploratory (Phase II)Interventional

SGL-TX-PTDM: SGLT2i effect on PTDM development and kidney allograft function in kidney transplant recipients: A randomized, double-blind, placebo controlled, national multicenter trial

This research is investigating a medication called Forxiga in people who have received a kidney transplant. The main goal is to see if Forxiga can help prevent a type of diabetes that sometimes develops after a kidney transplant. Researchers will also check if it improves how well the new kidney works. Half the participants will get Forxiga, and the other half will get a dummy pill (placebo). This is a 'double-blind' study, meaning neither the patient nor their doctor will know who is getting the real drug and who is getting the dummy pill until the study is over. The study will follow participants for 6 to 12 months to see the effects on their health.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Odense University Hospital

Enrolment target

184

Start

09 Mar 2026

Kidney transplant recipients

What is this study about?

This study is designed for people who have received a kidney transplant. After a kidney transplant, some people develop a new type of diabetes, which doctors call Post-Transplant Diabetes Mellitus (PTDM). This study is looking at whether a medicine called Forxiga can help prevent this from happening.

Researchers also want to see if Forxiga can help keep the new kidney working well. They will be closely monitoring several important health markers, including how well the kidneys are filtering waste (measured by something called eGFR), signs of protein in the urine, and blood pressure. They will also keep an eye on other aspects of health, like cholesterol levels and any potential side effects.

To make sure the results are fair and accurate, this study is set up as 'randomized' and 'double-blind'. 'Randomized' means participants are randomly chosen to receive either Forxiga or a dummy pill (placebo). 'Double-blind' means that neither you nor your study doctor will know whether you are receiving the active drug or the placebo until the study is finished. This helps ensure that everyone involved remains unbiased about the results. The study aims to follow people for 6 and 12 months to see the long-term effects of the treatment.

Key takeaways

Tests a drug (Forxiga) for new diabetes after kidney transplant.
Also checks if Forxiga improves kidney function.
Compares Forxiga to a dummy pill (placebo).
Study is 'double-blind' – no one knows who gets what.
Participation lasts 6 or 12 months with regular health checks.
Aims to understand better ways to care for transplant patients.

Who may be eligible?

This study is looking for adults who have received a kidney transplant. You must be at least 18 years old to take part.

Both men and women are welcome to participate in this research. The study will involve a close look at your medical history to make sure it's safe for you to join.

There might be other specific health requirements for joining, such as certain kidney function levels or blood test results. The study team will discuss all of these with you in detail to determine if you are a good fit.

Quick self-check

Are you 18 years old or older?
Have you had a kidney transplant?
Are you comfortable with taking a daily pill?
Are you able to attend regular clinic appointments for up to a year?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive either the study drug, Forxiga, or a dummy pill (placebo). Neither you nor your study doctor will know which one you are taking. You will take one tablet every day.

You will have several visits to the clinic over a period of 6 to 12 months. During these visits, the study team will carry out various assessments. This includes regular blood and urine tests to check your kidney function, blood sugar levels, cholesterol, and other important health markers. They will also measure your blood pressure. You might be asked to provide urine samples for special tests to look at kidney health. The total duration of your active involvement in the study will be either 6 or 12 months, depending on which follow-up period is assigned to you.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving a medication that could help prevent diabetes after your transplant or improve your kidney health, though it's also possible you could receive the dummy pill. All participants will also get close medical monitoring and care. However, there are potential risks, as any medication can have side effects, and some tests involve minor discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Denmark

Common questions

What is Forxiga?

Forxiga is a medication that helps your body remove sugar through your urine. It's used to treat diabetes and some heart and kidney conditions.

What is a placebo?

A placebo is a dummy pill that looks exactly like the real medication but contains no active drug. It helps researchers fairly compare the effects of the actual drug.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are taking the real drug or the dummy pill until the study is finished. This prevents bias in the results.

What is Post-Transplant Diabetes Mellitus?

It's a type of diabetes that can develop in some people after they've had an organ transplant, like a kidney transplant.

How long will I be in the study?

You will be followed for either 6 months or 12 months, during which you'll have regular check-ups and take the study medication or placebo.