In short
There is currently 1 ongoing clinical trial investigating treatment options for patients who have undergone heart transplantation and are experiencing complications. This trial focuses on preventing kidney damage in heart transplant recipients through the use of alternative immunosuppressive therapy.
Clinical trial locations
Study of belatacept, tacrolimus and ciclosporin in heart transplant patients at risk of kidney failure
This clinical trial is being conducted in France and focuses on heart transplant recipients who are at risk of developing chronic kidney failure, a common complication following transplantation. The study investigates whether belatacept, an immunosuppressive medication given through monthly intravenous infusions, can serve as a safer alternative to traditional anti-rejection medications that may harm the kidneys over time.
Who can participate:
The trial is open to adults aged 18 to 65 who received a heart transplant at least three months ago. To be eligible, you must have experienced a significant decline in kidney function, either showing a filtration rate below 30 ml/min or a decrease of more than 50% in kidney function between the time of transplant and three months afterward. You must test positive for Epstein-Barr virus antibodies and negative for donor-specific antibodies. Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during the study and for six weeks after. You must also be able to communicate clearly with the study team and have active social security coverage.
Who cannot participate:
You cannot join this trial if you are under 18 or over 65 years old. The study excludes individuals with active hepatitis B or C infections, active tuberculosis, or severe kidney dysfunction already requiring dialysis. You cannot participate if you have received any organ transplant other than your heart, are pregnant or breastfeeding, or have known allergic reactions to transplant medications. Additionally, those with active cancer or a history of cancer in the past five years, severe infections requiring hospitalization, serious uncontrolled heart rhythm problems, or severe lung disease requiring oxygen therapy are not eligible. Participation in other clinical trials within the past 30 days, substance abuse within the past year, or inability to provide informed consent also disqualify potential participants.
What the trial involves:
The main goal of this research is to determine whether belatacept can help preserve or improve kidney function in heart transplant patients when used alongside gradually reduced doses of traditional anti-rejection medications such as tacrolimus (sold as Advagraf or Prograf) and ciclosporin (Neoral). The study lasts for 12 months following your enrollment at three months post-transplantation.
Once enrolled, you will begin receiving monthly infusions of belatacept while your current calcineurin inhibitor medications are slowly reduced. Throughout the nine-month treatment period, you will undergo regular monitoring including blood tests to check kidney function, heart muscle biopsies to ensure the transplanted heart remains healthy, and tests for antibodies that might indicate rejection. Blood sugar levels will also be monitored to track any metabolic changes.
At the 12-month mark, the research team will perform a comprehensive evaluation comparing your kidney function at three months post-transplant to your current status, helping determine whether belatacept has successfully protected your kidney health while maintaining adequate immunosuppression to prevent heart rejection.
Investigational medications:
Belatacept is a biological medication administered through intravenous infusion that works by preventing your immune system from attacking the transplanted heart. Unlike traditional anti-rejection medications, belatacept uses a targeted approach that specifically blocks certain immune cell activation pathways, potentially causing less harm to the kidneys. It is currently approved for kidney transplant patients and is being studied in heart transplant recipients who are at risk of kidney damage.
Calcineurin inhibitors (tacrolimus and ciclosporin) are the standard anti-rejection medications used after heart transplantation. While highly effective at preventing organ rejection, these drugs can sometimes damage the kidneys over prolonged use. In this trial, these medications are gradually reduced as belatacept is introduced, with the goal of maintaining protection against rejection while reducing kidney-related side effects.
Summary
Currently, only one clinical trial is actively recruiting patients with complications following heart transplantation, specifically targeting those at risk of chronic kidney disease. This trial is being conducted exclusively in France and represents an important investigation into kidney-protective strategies for heart transplant recipients. The research focuses on belatacept as a potentially safer immunosuppressive alternative to traditional calcineurin inhibitors, which are known to contribute to kidney damage over time. The study reflects growing recognition of the need to balance effective prevention of heart rejection with preservation of kidney function in transplant patients. Patients interested in participating should discuss this opportunity with their transplant team to determine eligibility and understand the potential benefits and risks involved.
