Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Dapagliflozin for Kidney Protection in Heart Transplant Patients

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called dapagliflozin on individuals who have undergone a heart transplant and are experiencing kidney failure. The purpose of the study is to evaluate how dapagliflozin can help protect kidney function in these patients. Dapagliflozin is a medication that comes in the form of a film-coated tablet and is taken orally.

Participants in the study will be randomly assigned to receive either dapagliflozin or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for about 12 months, during which time the participants' kidney function will be closely monitored. This will involve regular check-ups and tests to assess how well the kidneys are working. The main focus will be on the change in kidney function from the start of the study to the end.

In addition to monitoring kidney function, the study will also look at other health indicators, such as body weight, the ratio of certain proteins in the urine, and blood sugar levels in participants with diabetes. These additional measurements will help provide a comprehensive understanding of how dapagliflozin affects overall health in heart transplant recipients with kidney issues. The study aims to gather valuable information that could lead to improved treatment options for these patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have received a heart transplant at least one year prior and be at least 18 years old.

    The patient must have provided informed consent according to Good Clinical Practice and national or regional regulations.

    The patient must have an estimated glomerular filtration rate (eGFR) of at least 25 ml/min/1.73 m², as assessed by the MDRD formula.

  2. Step 2

    Randomization and medication

    The patient will be randomly assigned to receive either dapagliflozin or a placebo.

    The medication is administered orally in the form of film-coated tablets, with a dosage of 10 mg.

  3. Step 3

    Treatment duration

    The treatment will last for 12 months.

    The primary endpoint is the change in eGFR from two weeks to the end of the treatment period.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, various health parameters will be monitored, including body weight and the albumin/creatinine ratio in urine.

    For patients with diabetes, changes in blood levels of glycated hemoglobin (HbA1c) will be assessed.

    Exploratory endpoints include changes in body composition and biomarkers of renal damage, such as Cystatin-C and Lipocalin (NGAL).

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by December 31, 2027.

    The final assessment will include the evaluation of the primary and secondary endpoints to determine the effect of dapagliflozin on renal function in heart transplant recipients.

Who can join the trial?

5 criteria

  • Must have received a heart transplant at least 1 year ago.
  • Must be 18 years of age or older.
  • Must have given and documented their agreement to participate, following guidelines for ethical research practices.
  • Must have an estimated glomerular filtration rate (a measure of kidney function) of at least 25 ml/min/1.73 m², as calculated by a specific method called the MDRD formula.
  • Must be considered by the study doctor to be suitable for being randomly assigned to receive either the study drug, dapagliflozin, or a placebo (a substance with no active drug).

Who cannot join the trial?

2 criteria

  • Patients with **kidney failure** cannot participate. This means if your kidneys are not working well, you cannot join the study.
  • Patients who have had a **heart transplant** are not eligible. This means if you have received a new heart from a donor, you cannot take part in the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Dapagliflozin is a medication used in this trial to assess its impact on kidney function in patients who have received a heart transplant. It is typically used to help control blood sugar levels in people with type 2 diabetes, but in this study, its potential benefits for protecting kidney function in heart transplant recipients are being evaluated.

What is already known about the treatment

Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in protecting kidney function in patients who have undergone a heart transplant. The main therapeutic indications for dapagliflozin include managing kidney failure and supporting heart transplant recipients. At the molecular level, dapagliflozin works by inhibiting a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2), which helps reduce blood sugar levels and may have protective effects on the kidneys. It is classified pharmacologically as an SGLT2 inhibitor.

Investigated diseases

  • Kidney Failure

    Kidney failure occurs when the kidneys lose their ability to filter waste and excess fluids from the blood effectively. This condition can develop rapidly or gradually over time, depending on the underlying cause. As kidney function declines, waste products and fluids can build up in the body, leading to symptoms such as swelling, fatigue, and difficulty concentrating. In the early stages, there may be few noticeable symptoms, but as the condition progresses, more severe symptoms can develop. Chronic kidney failure is often the result of long-term conditions like diabetes or high blood pressure. Acute kidney failure, on the other hand, can occur suddenly due to injury or illness.

  • Heart Transplant

    A heart transplant is a surgical procedure in which a diseased or failing heart is replaced with a healthier donor heart. This procedure is typically considered when other treatments for heart conditions have not been successful. The progression of heart disease leading to a transplant can vary, often involving conditions like coronary artery disease or cardiomyopathy. Patients may experience symptoms such as severe fatigue, shortness of breath, and fluid retention as their heart function declines. The process of receiving a heart transplant involves extensive evaluation and waiting for a suitable donor. Post-transplant, patients require lifelong medical care to manage the risk of rejection and other complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506486-60-01Protocol codeD1699L00015Estimated enrolment270 patientsSponsorOslo University Hospital HF

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.