Clinical Trials for Delayed Graft Function
Delayed graft function is a complication that can occur after kidney transplantation, where the new kidney does not start working immediately. Currently, there are 2 ongoing clinical trials exploring ways to improve outcomes for patients at risk of or experiencing this condition. These studies are testing different approaches, including new medications and changes to standard immunosuppressive therapy, to help transplanted kidneys function more effectively.
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 designed for elderly patients who have recently received a kidney transplant. The main focus is to compare two different medication approaches: using tacrolimus alone versus combining three medications (tacrolimus, mycophenolate mofetil, and prednisone). The goal is to find out whether using fewer medications can help reduce infections while still protecting the transplanted kidney from rejection.
Who can participate: Patients aged 60 years or older who are receiving either a deceased donor or living donor kidney transplant can join this study. Participants must not have donor-specific anti-HLA antibodies at the time of transplantation. Previous kidney transplant recipients can participate if they meet all other requirements. Both men and women are eligible, and participants must be able to understand and sign an informed consent document.
Who cannot participate: The study excludes individuals who are below 18 years or above 65 years of age. Those who have had previous organ transplants other than the current kidney transplant, have active or chronic infections, are pregnant or breastfeeding, or have known allergies to immunosuppressive medications are not eligible. Additionally, people with severe heart, liver, or lung disease, active cancer or a history of cancer in the past 5 years, uncontrolled diabetes, or mental conditions that could affect their ability to follow study procedures cannot participate. Other exclusions include participation in other clinical trials within the past 30 days, history of substance abuse within the past 2 years, severe kidney dysfunction despite transplantation, history of organ rejection episodes in the past 6 months, and any unstable medical condition that could interfere with study participation.
Study medications: Tacrolimus is an immunosuppressive medication that helps prevent organ rejection by weakening the immune system’s response to the transplanted kidney. The study is examining whether using tacrolimus alone is as effective as the standard triple therapy, which combines tacrolimus with mycophenolate mofetil and prednisone. All medications are taken by mouth daily.
What happens during the study: Participants will be followed for three years after their kidney transplant. Regular blood tests will monitor kidney function, including eGFR measurements and 24-hour urine collection. Blood tests will also check for the presence of viruses such as cytomegalovirus and BK-virus. Additional immune system monitoring will occur at 6 months, 1 year, 2 years, and 3 years. Throughout the study, participants will have regular medical appointments to assess their health status and complete quality of life assessments.
Study on ARGX-117 for Improving Kidney Function in Patients with Delayed Graft Function After Deceased Donor Transplant
This clinical trial focuses on patients who have received a kidney transplant from a deceased donor and are at risk of experiencing delayed graft function, meaning the new kidney may not start working as quickly as expected. The study is testing an experimental medication called ARGX-117, which is administered directly into the bloodstream through a vein.
Who can participate: Eligible participants must be at least 18 years old and less than 70 years old when signing the informed consent form. They must have a dry body weight of less than 120 kg and a body mass index below 40 kg/m². Participants should be diagnosed with end-stage renal disease and have been stable on regular dialysis for at least 3 months. The study accepts patients receiving a first-time or second-time single kidney transplant from a deceased donor (either donation after circulatory death or donation after brain death). Participants must be ABO compatible with the donor kidney, have a negative cross match, and have received or be willing to receive vaccinations for certain infections. COVID-19 vaccinations as required by the study location are also necessary.
Who cannot participate: The study excludes patients with a history of severe allergic reactions to any of the study medications, those currently participating in another clinical trial, or those with uncontrolled infections. Patients who have received an organ transplant other than a kidney, have a history of cancer that is not in remission, are pregnant or breastfeeding, or have a history of drug or alcohol abuse are not eligible. Any medical condition that study doctors believe would make it unsafe for participation is also grounds for exclusion.
Study medication: ARGX-117 is an investigational immunomodulatory agent being studied for its potential to improve kidney function by modulating the immune response. The medication works at the molecular level to potentially reduce inflammation and improve graft acceptance. It is administered intravenously and is not yet approved for general medical use.
What happens during the study: This is a double-blinded study, meaning neither participants nor researchers will know who is receiving ARGX-117 or the placebo. After joining, participants will be randomly assigned to receive either the medication or placebo through an intravenous infusion. Regular monitoring will assess kidney function, including eGFR measurements at 24 weeks after transplant. The study will track delayed graft function, dialysis duration, and safety outcomes such as adverse events. Follow-up evaluations will continue up to 52 weeks post-transplant, monitoring eGFR, dialysis-free survival, antibodies against ARGX-117, and other health indicators. The study is expected to conclude by April 2026.
Summary
Currently, there are 2 ongoing clinical trials addressing delayed graft function in kidney transplant patients. These studies take different approaches to improving outcomes after transplantation. One trial focuses specifically on elderly patients in the Netherlands and examines whether reducing the number of immunosuppressive medications can lower infection risks while maintaining adequate protection against rejection. The other trial has a broader European reach across 8 countries (Italy, Portugal, Belgium, Spain, Austria, France, and Sweden) and tests a new investigational drug called ARGX-117 for patients at risk of delayed graft function.
The concentration of one trial across multiple European countries suggests a coordinated effort to recruit sufficient participants for this condition, while the Netherlands-based study addresses the specific needs of elderly transplant recipients. Both trials reflect current concerns in transplant medicine: balancing effective immunosuppression with the risks of over-medication, particularly infections, and finding ways to improve early kidney function after transplantation.
