Ongoing Clinical Trials for Graft Infection
Currently, there are 2 ongoing clinical trials investigating new approaches to prevent and treat infections related to organ transplantation. These studies are taking place in the Netherlands and Italy, focusing on kidney transplant recipients and stem cell transplant patients who face challenges with viral infections that can affect transplanted organs and overall health.
Clinical trial locations
- Italy
- Netherlands
Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections
This study is designed for elderly patients who have received a kidney transplant and aims to find the best way to prevent infections while protecting the transplanted organ. The research compares two different medication approaches: using tacrolimus alone or combining it with two other medications, mycophenolate mofetil and prednisone.
Who can participate: The trial is open to patients who are 60 years of age or older and are receiving either a deceased donor or living donor kidney transplant. Both men and women can join the study, including those who have had a previous kidney transplant. Importantly, patients must not have donor-specific anti-HLA antibodies at the time of transplantation, which are proteins in the blood that could react against the donor’s tissue. All participants must be able to understand and sign a written informed consent document.
Who cannot participate: The study excludes patients who have had organ transplants other than the current kidney transplant, those with active or chronic infections, pregnant or breastfeeding women, and individuals with known allergies to immunosuppressive medications. Patients with severe heart, liver, or lung disease, active cancer or a history of cancer in the past 5 years, uncontrolled diabetes, or severe kidney dysfunction despite transplantation are also excluded. Additionally, anyone with mental conditions that could affect their ability to follow study procedures, participation in other clinical trials within the past 30 days, history of substance abuse within the past 2 years, or inability to provide informed consent cannot join.
Study focus: The main goal is to determine if using fewer medications can reduce the risk of infections and improve quality of life in older transplant recipients. Researchers will follow participants for three years after their kidney transplant, monitoring the occurrence of infections, the function of the transplanted kidney, and overall patient well-being. Regular medical tests will check how well the transplanted kidney is working and track any complications that may occur. Blood tests will also be performed to check for the presence of viruses, including cytomegalovirus and BK-virus.
Investigational treatments: The trial uses tacrolimus, an immunosuppressive medication that helps prevent organ rejection after kidney transplantation by weakening the immune system’s response to the transplanted kidney. This medication is being studied as a single-drug therapy approach and compared against the standard triple immunosuppressive therapy, which combines tacrolimus with mycophenolate mofetil and prednisone. All medications are taken by mouth according to the prescribed schedule.
Study on Virus-Specific T-Cells for Treating Resistant Viral Infections in Young Patients After Stem Cell Transplant
This clinical trial offers a new treatment approach for young patients who have undergone a stem cell transplant and are experiencing viral infections that do not respond to regular drug treatments. The study focuses on infections caused by Cytomegalovirus, Adenovirus, Epstein-Barr virus, and BK virus, which can be particularly challenging after transplantation.
Who can participate: The study is open to patients between the ages of 0 and 30 years who have had an allogeneic transplant, meaning they received stem cells from a donor. Participants must have a viral infection or reactivation of viruses like CMV, EBV, ADV, or BK. The patient or their parent or legal guardian must provide informed consent. Eligible patients should not have any other severe uncontrolled infections, should have a life expectancy of more than 30 days, and should not have uncontrolled Graft versus Host Disease, which is a condition where the donor cells attack the patient’s body. Kidney and liver function must also meet specific criteria related to the viral infection.
Who cannot participate: Patients who have not received an allogeneic hematopoietic stem cell transplant or who have not developed post-transplant viral reactivation are excluded. The study also excludes patients whose viral reactivation is not resistant to regular medicines, meaning the virus can still be treated with standard therapies. Additionally, patients older than 30 years cannot participate.
Study focus: The main goal is to evaluate the safety of a special type of cell therapy using virus-specific T-cells, which are immune cells designed to target and fight the specific viruses causing the infections. The study will also examine how well the treatment works in reducing the viral infections and improving the overall health of participants. Patients will be monitored for any side effects or improvements in their condition, including regular assessments of organ health, overall survival, and the effectiveness of the immune response against the virus.
Investigational treatment: The therapy involves virus-specific T-cells that are selected from a family donor in a laboratory setting. These T-cells are specifically trained to target and fight viruses. The treatment is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream. This approach is being tested to help the patient’s immune system combat infections like Adenovirus, Epstein-Barr virus, Cytomegalovirus, and BK virus in young patients who have undergone stem cell transplantation.
Summary
These two clinical trials represent different approaches to managing infection-related complications in transplant patients. The first study, conducted in the Netherlands, focuses on elderly kidney transplant recipients and explores whether simplifying medication regimens can reduce infection risks while maintaining organ protection. The second trial, taking place in Italy, targets young stem cell transplant patients and investigates an innovative cell therapy for treating resistant viral infections.
Both studies address the significant challenge of infections in transplant recipients, who have weakened immune systems due to the medications needed to prevent organ rejection. The Netherlands trial specifically examines tacrolimus-based immunosuppression strategies, while the Italian study pioneers the use of virus-specific T-cell therapy as a treatment option when standard antiviral medications fail. These trials reflect the ongoing research efforts to improve outcomes and quality of life for transplant patients of different age groups facing infection-related complications.
