Clinical Trials for Transplantation Complications
This article provides information about 2 ongoing clinical trials investigating treatment approaches for complications related to organ transplantation. These studies focus on elderly kidney transplant recipients and patients with Type 1 diabetes undergoing simultaneous pancreas and kidney transplantation, examining ways to reduce infection risks and surgical complications.
Clinical trial locations
- Czechia
- Netherlands
Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections
This trial is being conducted in the Netherlands and focuses on elderly patients aged 60 years and older who have received a kidney transplant. The study compares two approaches to preventing organ rejection: using tacrolimus alone versus the standard combination of three medications (tacrolimus, mycophenolate mofetil, and prednisone).
Who can participate:
- Patients who are 60 years of age or older
- Those receiving either a deceased donor or living donor kidney transplant
- Patients without donor-specific anti-HLA antibodies at the time of transplantation
- Previous kidney transplant recipients who meet all other criteria
- Both men and women
- Those able to understand and sign informed consent
Who cannot participate:
- Patients below 18 years or above 65 years
- Those with previous organ transplants other than the current kidney transplant
- Patients with active or chronic infections
- Pregnant or breastfeeding women
- Those with known allergies to immunosuppressive medications
- Patients with severe heart, liver, or lung disease
- Those with active cancer or history of cancer in the past 5 years
- Patients with uncontrolled diabetes
- Those with mental conditions affecting ability to follow study procedures
- Participants in other clinical trials within the past 30 days
Main focus: The study aims to determine if using fewer medications can reduce the risk of infections and improve quality of life in older transplant recipients while still protecting against organ rejection. Participants will be followed for three years after their kidney transplant, during which researchers will monitor infection rates, kidney function, and overall patient well-being.
Investigational drugs: The trial examines tacrolimus as a single-drug therapy compared to the standard triple combination therapy. Tacrolimus is an immunosuppressive medication that weakens the immune system’s response to the transplanted kidney. The standard approach combines tacrolimus with mycophenolate mofetil and prednisone, both of which also help prevent organ rejection through different mechanisms.
Study on Sirolimus and Mycophenolate Mofetil for Reducing Hernia Risk in Type 1 Diabetes Patients with End-Stage Kidney Disease Undergoing Pancreas and Kidney Transplantation
This clinical trial is taking place in Czechia and focuses on patients with Type 1 diabetes who have reached end-stage kidney disease and are undergoing simultaneous pancreas and kidney transplantation. The study compares two different immunosuppressive medications to determine which is more effective at reducing the risk of incisional hernia after the transplant procedure.
Who can participate:
- Male or female patients between 18 to 65 years old
- Those with end-stage kidney disease due to Type 1 diabetes
- Patients scheduled for a primary simultaneous pancreas and kidney transplant from a deceased donor
Who cannot participate:
- Patients without end-stage kidney disease caused by Type 1 diabetes
- Those not undergoing simultaneous pancreas and kidney transplantation
- Patients not being treated with either sirolimus or mycophenolate mofetil as part of their immunosuppressive therapy
- Those not at risk of developing an incisional hernia after transplantation
Main focus: The primary goal is to compare the risk of developing an incisional hernia, which is a bulge that can occur at the site of the surgical incision, following the transplant procedure. The study will also monitor other potential complications such as infections or surgical issues, as well as patient and organ survival rates and any signs of organ rejection. Throughout the study, various health indicators will be assessed, including blood sugar levels, kidney function, and any progression of diabetes-related complications. The trial is expected to conclude by May 31, 2028.
Investigational drugs: Participants will receive either sirolimus or mycophenolate mofetil, both taken orally. Sirolimus works by inhibiting a protein called mTOR, which is involved in cell growth and proliferation. Mycophenolate mofetil works by inhibiting an enzyme necessary for the growth of certain immune cells. Both medications suppress the immune system to help prevent the body from rejecting the transplanted organs.
Summary
These two clinical trials address different aspects of transplantation complications in specific patient populations. The Netherlands-based study focuses on elderly kidney transplant recipients and aims to simplify medication regimens to reduce infection risks, while the Czech study addresses surgical complications in patients with Type 1 diabetes undergoing dual organ transplantation.
Both trials investigate immunosuppressive medications, which are essential for preventing organ rejection but can also increase the risk of complications. The Dutch trial examines whether reducing the number of medications might benefit elderly patients, while the Czech trial compares two different immunosuppressive approaches to minimize hernia risk.
Notably, mycophenolate mofetil appears in both trials, highlighting its importance in transplantation medicine. The studies represent different approaches to optimizing patient outcomes after transplantation, with one focusing on infection prevention and the other on surgical complications.