Ongoing Clinical Trials for Liver Transplant Patients
There are currently 4 clinical trials underway exploring treatments and care approaches for liver transplant patients. These studies are being conducted across France, Germany, and the Netherlands, focusing on preventing kidney complications, improving medication management, and supporting cognitive function after transplantation.
Clinical trial locations
- France
- Germany
- Netherlands
Study of Human Albumin Treatment to Prevent Kidney Dysfunction in Adult Patients After Liver Transplantation
This French trial examines whether maintaining higher levels of albumin in the blood can protect kidney function during the critical first week after liver transplant surgery.
Who can participate:
- Adults aged 18 years or older
- Patients scheduled to receive their first liver transplant from a deceased donor
- Individuals able to understand and provide written consent
- Both men and women are eligible
Who cannot participate:
- Those under 18 years of age
- Patients who have previously received a liver transplant
- Individuals with known allergies to albumin
- Patients with severe kidney failure requiring dialysis before transplantation
- Pregnant or breastfeeding women
- Those participating in other clinical trials simultaneously
- Patients unable to provide informed consent
- Individuals with severe heart conditions or active infections
- Those with uncontrolled blood pressure
What the study involves: The trial compares two approaches to administering human albumin solution after surgery. One group receives albumin to maintain blood levels above 30 grams per liter, while the control group receives albumin only when levels drop to 20 grams per liter or below. Treatment continues for five days, with kidney function closely monitored throughout. Doctors will also track infection rates, time in intensive care, liver function, and overall recovery for up to 28 days after surgery.
Investigational treatment: Human albumin is a naturally occurring blood protein given through intravenous infusion. It helps maintain proper fluid balance in blood vessels and supports kidney function during the stressful post-transplant period.
Study on How Pantoprazole Affects the Absorption of Mycophenolate Mofetil in Post-Transplant Patients
This Dutch study investigates how pantoprazole, a stomach acid-reducing medication, affects the absorption of mycophenolate mofetil, an important anti-rejection drug used after transplantation.
Who can participate:
- Healthy male volunteers only
- Ages between 18 and 55 years
- Body weight over 50 kg with Body Mass Index between 18.5 and 30 kg/m²
- Normal vital signs: blood pressure between 90-149/50-89 mmHg and heart rate between 50-90 beats per minute
- Normal laboratory test results for blood and urine
- Able to understand the study and provide written informed consent
Who cannot participate:
- Individuals who are not post-transplant recipients
- All female participants
- Anyone under 18 or over 65 years of age
- Members of vulnerable populations with limited decision-making capacity
What the study involves: Participants will receive different formulations of mycophenolate mofetil, including both generic and brand-name versions, along with pantoprazole. Researchers will measure how well the body absorbs the medication by tracking drug concentrations in the blood over time. The study aims to determine whether these formulations work equivalently when taken with a proton pump inhibitor.
Investigational treatments: The study examines pantoprazole (a proton pump inhibitor given as a 40 mg tablet) and mycophenolate mofetil (an immunosuppressant given as a 500 mg tablet). The goal is to understand how their interaction affects medication absorption and effectiveness in preventing organ rejection.
Study on the Effect of Arginine-Vasopressin and Noradrenaline Tartrate on Acute Kidney Injury in Liver Transplant Patients
This French trial tests whether a low dose of arginine-vasopressin given during surgery can reduce the risk of acute kidney injury in the days following transplantation.
Who can participate:
- Adults aged 18 years or older
- Patients scheduled for liver transplantation
- Individuals who receive clear information and provide signed informed consent
- Those affiliated with the Social Security system
Who cannot participate:
- Patients who have already had a liver transplant
- Those with existing acute kidney injury (sudden decrease in kidney function)
What the study involves: During surgery, participants receive a low-dose infusion of arginine-vasopressin directly into the bloodstream. After surgery, kidney function is closely monitored for the first seven days to detect any signs of acute kidney injury. The study also tracks the need for blood transfusions, additional treatments, and time spent in intensive care. Recovery is followed for 30 days to assess overall survival and health status.
Investigational treatment: Arginine-vasopressin is a hormone that helps regulate water balance and blood pressure. By supplementing with this hormone during surgery, researchers hope to support kidney function and improve outcomes for patients undergoing liver transplants.
Study on Cognitive Function in Liver Transplant Patients Comparing Once-Daily and Twice-Daily Tacrolimus Formulations
This German study compares two formulations of tacrolimus, an anti-rejection medication, to determine whether the once-daily version can improve patients’ attention and memory compared to the twice-daily version.
Who can participate:
- Adults between 20 and 75 years old
- Patients who had a liver transplant at least 12 months ago
- Currently taking a twice-daily formulation of tacrolimus for at least 3 months
- Individuals experiencing at least mild cognitive impairment (difficulties with memory or thinking skills)
- Able to provide written informed consent
Who cannot participate:
- The study specifically excludes patients who have not had a liver transplant, as it focuses on post-transplant populations
What the study involves: Participants are assigned to take either Envarsus (once-daily tacrolimus) or Prograf (twice-daily tacrolimus) for up to 12 months. Cognitive function is assessed through multiple tests measuring attention, memory, and information processing at the beginning of the study and at 6-month and 12-month follow-ups. The study also measures quality of life and everyday functioning with input from family members or caregivers. Liver and kidney function are monitored throughout to ensure safety.
Investigational treatment: Tacrolimus (Envarsus) is an immunosuppressant that prevents the body from rejecting the transplanted liver. The once-daily prolonged-release formulation may offer advantages in terms of convenience and potentially improved cognitive outcomes compared to taking medication twice daily.
Summary
The four ongoing clinical trials for liver transplant patients reflect important concerns in post-transplant care. Two studies in France focus on preventing acute kidney injury, a common and serious complication after transplantation, using different approaches: human albumin and arginine-vasopressin. The Netherlands study addresses medication interactions that may affect treatment effectiveness, while the German trial examines cognitive function and quality of life in long-term transplant survivors.
Notably, kidney protection is a major theme, featured in half of these trials, highlighting the vulnerability of kidney function during and after liver transplantation. The studies employ diverse strategies, from protein supplementation to hormone therapy, reflecting ongoing efforts to optimize patient outcomes beyond organ survival. The German cognitive function study addresses an often-overlooked aspect of transplant recovery: the impact of immunosuppressive medications on mental function and daily life.
These trials collectively demonstrate a comprehensive approach to transplant care, addressing immediate surgical risks, medication optimization, and long-term quality of life for patients who have undergone this life-saving procedure.
