Ongoing Clinical Trials for Complications of Transplanted Kidney
There are currently 3 ongoing clinical trials investigating various approaches to prevent and manage complications after kidney transplantation. These studies focus on optimizing immunosuppressive medication regimens to reduce infections in elderly patients, preventing BK virus infection through immune system monitoring, and improving kidney function in patients experiencing delayed graft function after receiving a kidney from a deceased donor. Trials are being conducted across multiple European countries including Spain, Netherlands, Italy, Portugal, Belgium, Austria, France, and Sweden.
Clinical trial locations
- Austria
- Belgium
- Espagne
- France
- Italy
- Netherlands
- Portugal
- Spain
- Sweden
Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections
This study is taking place in the Netherlands and focuses specifically on elderly patients aged 60 years and older who have received a kidney transplant. The research compares two different medication approaches: using tacrolimus alone versus the standard combination of three medications including tacrolimus, mycophenolate mofetil, and prednisone.
Main inclusion criteria: To participate, patients must be 60 years of age or older and receiving either a deceased donor or living donor kidney transplant. Previous kidney transplant recipients can join if they meet all other requirements. 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. Both men and women can participate, and patients must be able to understand and sign an informed consent document.
Main exclusion criteria: Patients cannot participate if they are younger than 18 or older than 65 years of age. Other exclusions include having received previous organ transplants other than the current kidney transplant, active or chronic infections, current pregnancy or breastfeeding, and known allergies to immunosuppressive medications. Additional exclusions include severe heart, liver, or lung disease, active cancer or history of cancer in the past 5 years, uncontrolled diabetes, mental conditions affecting ability to follow procedures, and participation in other clinical trials within the past 30 days.
Study focus: The primary goal is to determine if using fewer medications can reduce the risk of infections and improve quality of life in older transplant recipients. Participants will be followed for three years after their kidney transplant. During this time, researchers will monitor the occurrence of infections, kidney function through regular blood tests measuring estimated glomerular filtration rate and 24-hour urine collection, and quality of life assessments. Blood tests will also check for the presence of viruses, including cytomegalovirus and BK-virus, with additional immune system monitoring at 6 months, 1 year, 2 years, and 3 years.
Investigational drugs: Tacrolimus is an immunosuppressive medication that helps prevent organ rejection by weakening the immune system’s response to the transplanted kidney. This medication is being studied as a single-drug therapy approach. The study compares this to standard triple immunosuppressive therapy, which includes a combination of three different medications typically used after kidney transplantation to prevent organ rejection.
Study on Preventing BK Virus Infection in Kidney Transplant Patients Using Mycophenolic Acid, Mycophenolate Mofetil, and Sirolimus
This clinical trial is taking place in Spain and focuses on preventing viral infections caused by the BK virus after kidney transplantation. The study examines how the body’s immune system can be strengthened to protect against this virus while patients take medications to suppress their immune system to prevent organ rejection.
Main inclusion criteria: Patients must be at least 18 years old and able to give written informed consent. They must be receiving a kidney transplant and have a maintenance immunosuppressive regimen based on either tacrolimus combined with mycophenolate mofetil or mycophenolic acid plus corticosteroids, or tacrolimus combined with rapamycin plus corticosteroids. Patients must have a detectable viral load of the BK virus in their blood as measured by PCR. The kidney transplant must have occurred within the last 12 months before the viral load was detected. Additionally, patients must have stable kidney function with an estimated glomerular filtration rate of at least 35 ml/min/1.73 m² and a urine protein/creatinine ratio value of less than 1 g/g.
Main exclusion criteria: Patients who have had a kidney transplant less than 3 months ago cannot participate. Other exclusions include currently participating in another clinical trial, history of severe allergic reactions to medications, active infections requiring treatment, and history of cancer within the last 5 years except for certain skin cancers. Pregnant or breastfeeding patients are excluded, as well as those with severe liver disease, uncontrolled high blood pressure, or history of drug or alcohol abuse within the last year. Patients unable to follow study procedures or attend study visits are also excluded.
Study focus: The study aims to understand how different combinations of immunosuppressive medications affect the immune system’s ability to fight the BK virus. Participants will be monitored for changes in their immune response and viral load over a period of up to 16 weeks. The study will examine specific immune cells, such as T cells and B cells, and analyze how they respond to the virus, including looking at specific proteins and antibodies that play a role in fighting infections.
Investigational drugs: The study examines mTor-i drugs, which are a type of medication used to help prevent the body from rejecting a transplanted kidney. These drugs work by blocking a specific pathway in the immune system, reducing the activity of immune cells that might attack the new kidney. The study also involves other immunosuppressive medications including tacrolimus, mycophenolate mofetil, mycophenolic acid, and sirolimus.
Study on ARGX-117 for Improving Kidney Function in Patients with Delayed Graft Function After Deceased Donor Transplant
This clinical trial is being conducted across multiple European countries including Italy, Portugal, Belgium, Spain, Austria, France, and Sweden. The study focuses on a condition called delayed graft function, which occurs when a newly transplanted kidney from a deceased donor does not start working as quickly as expected.
Main inclusion criteria: Participants must be at least the local legal age of consent for clinical studies, at least 18 years old, and less than 70 years old. They must have received required COVID-19 vaccinations and be able to provide signed informed consent and follow study requirements. Patients must agree to use birth control methods as required and have a dry body weight of less than 120 kg and a body mass index of less than 40 kg/m². Participants must be diagnosed with end-stage renal disease and have been stable on regular dialysis for at least 3 months. They must be receiving a first-time or second-time single kidney transplant from a deceased donor, be blood type compatible with the donor kidney, and have a negative cross match test. Patients must also have received or be willing to receive specific vaccinations before or after the transplant.
Main exclusion criteria: Patients with a history of severe allergic reactions to any of the study medications cannot participate. Other exclusions include currently participating in another clinical trial, having a known infection that is not well controlled, having received an organ transplant other than a kidney, and having a history of cancer that is not in remission. Pregnant or breastfeeding patients are excluded, as well as those with a history of drug or alcohol abuse or any other medical condition that would make participation unsafe.
Study focus: The study is testing a treatment called ARGX-117, which is administered as an intravenous infusion directly into the bloodstream. Participants are randomly assigned to receive either ARGX-117 or a placebo in a double-blinded design, meaning neither participants nor researchers know who receives the actual treatment. The study takes place over several weeks with regular check-ups to monitor health and kidney function. The main goal is to assess how well the transplanted kidney is working 24 weeks after the transplant. Other aspects being monitored include the number of participants who experience delayed graft function, the duration of any dialysis treatment needed, overall safety outcomes, how the body processes ARGX-117, and any potential immune responses to the treatment.
Investigational drug: ARGX-117 is a medication being studied to see if it can help improve the function of a transplanted kidney from a deceased donor. It is currently in the investigational stage and not yet approved for general medical use. The medication is being evaluated for its ability to enhance the function of transplanted kidneys by modulating the immune response. ARGX-117 is classified as an immunomodulatory agent, working at the molecular level to potentially reduce inflammation and improve graft acceptance.
Summary
The three ongoing clinical trials for complications of transplanted kidney represent different approaches to improving outcomes after kidney transplantation. A notable observation is that one trial focuses exclusively on elderly patients aged 60 and older in the Netherlands, recognizing that this age group may benefit from a simplified medication regimen with fewer drugs to reduce infection risks while maintaining adequate protection against organ rejection.
Geographically, the trials show a strong concentration in European countries, with the ARGX-117 study being the most widely distributed across eight countries including Spain, Italy, Portugal, Belgium, Austria, France, Sweden, and appearing in locations listed as both Spain and Espagne. The other two trials are more focused, with one in Spain studying BK virus prevention and one in the Netherlands examining medication regimens for elderly patients.
The studies address three distinct complications: infection risks in elderly recipients, BK virus infection prevention, and delayed graft function in kidneys from deceased donors. The investigational approaches vary significantly, from simplifying existing medication regimens with tacrolimus to studying new medications like ARGX-117 and examining how different immunosuppressive combinations affect viral immunity. All three trials emphasize careful monitoring of kidney function and immune responses, reflecting the delicate balance needed between preventing organ rejection and maintaining adequate immune function to fight infections.
