Study on Dapagliflozin for Kidney Protection in Heart Transplant Patients

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Oslo University Hospital HF Oslo Norway
Lund University Hospital Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Karolinska University Hospital Solna Sweden
Ecwmklt Ugjnsalfbmvw Mpccuoe Cvgxmci Rpclwkexh (mhdsxca Mki Rotterdam The Netherlands
Uorugoiaxjdm Mwzgavg Cefctox Gmcdouxia Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not recruiting
02.10.2023
Sweden Sweden
Not recruiting
02.10.2023
The Netherlands The Netherlands
Not recruiting
02.10.2023

Trial locations

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.

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 ID:
2023-506486-60-01
Protocol code:
D1699L00015
NCT ID:
NCT05321706
Trial Phase:
Therapeutic confirmatory (Phase III)

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