Ongoing Clinical Trials for Acute Graft Versus Host Disease In Skin
This article provides information about 2 ongoing clinical trials related to Acute Graft Versus Host Disease In Skin. These studies are being conducted in several European countries and focus on different approaches to managing complications that can occur after transplantation procedures. The trials examine various medication strategies aimed at reducing side effects and improving patient outcomes.
Clinical trial locations
- Germany
- Italy
- Netherlands
- Poland
- Sweden
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 who have received a kidney transplant. The study compares two different medication approaches to prevent organ rejection while potentially reducing infection risks in older transplant recipients.
Main inclusion criteria: The study accepts patients who are 60 years of age or older and are receiving either a deceased donor or living donor kidney transplant. Participants must not have donor-specific antibodies present at the time of transplantation. Both men and women can participate, and previous kidney transplant recipients are eligible if they meet all other requirements. Patients must be able to understand and provide written informed consent.
Main exclusion criteria: The study excludes individuals with ages below 18 or above 65 years, those with previous organ transplants other than the current kidney transplant, and patients with active or chronic infections. Other exclusion criteria include current pregnancy or breastfeeding, known allergies to immunosuppressive medications, severe heart, liver, or lung disease, active cancer or recent cancer history within the past 5 years, uncontrolled diabetes, mental conditions affecting ability to follow procedures, participation in other recent clinical trials, substance abuse history within the past 2 years, severe kidney dysfunction despite transplantation, recent organ rejection episodes, and unstable medical conditions.
Focus and goal: The trial examines whether using tacrolimus as a single medication works better than the standard three-drug combination of tacrolimus, mycophenolate mofetil, and prednisone. The main goal is to determine if using fewer medications can reduce infection risks while still effectively preventing organ rejection in elderly transplant recipients. The study follows participants for three years, monitoring infection occurrence, kidney function, and overall quality of life through regular medical tests and assessments.
Investigational drugs: The trial studies tacrolimus as a potential single-drug therapy approach. Tacrolimus is an immunosuppressive medication that weakens the immune system’s response to the transplanted kidney. This is compared against the standard triple therapy that combines three different immunosuppressive medications typically used after kidney transplantation. All medications are taken by mouth daily.
Study on Long-Term Safety of Ruxolitinib, Panobinostat, and Siremadlin for Patients Continuing Treatment from Previous Studies
This trial is being conducted across multiple European countries including Sweden, Poland, Germany, and Italy. The study evaluates the long-term safety of treatments for patients who have previously participated in studies involving ruxolitinib, either alone or in combination with other medications.
Main inclusion criteria: Patients must be currently enrolled in a previous study sponsored by Novartis or Incyte and receiving treatment with ruxolitinib alone or combined with panobinostat, siremadlin, or rineterkib. Participants must have met all requirements of their original study and must be benefiting from the treatment as determined by their investigator. The study accepts both male and female patients from different age groups, including children, teenagers, and adults.
Main exclusion criteria: The study excludes patients who are not within the specified age range, those who do not meet the specific disease criteria outlined in the parent protocol, and patients who are not part of the clinical trial group specified for this study.
Focus and goal: The trial aims to gather information on the long-term safety of ruxolitinib and its combinations with other medications. Participants continue their treatment as they have been doing in their previous studies, while researchers monitor the frequency and severity of any side effects or adverse events. The study is open-label, meaning both participants and researchers know which treatment is being administered. Regular assessments help determine any clinical benefits patients may experience from the continued treatment. The study is expected to continue until September 2027.
Investigational drugs: The trial involves ruxolitinib, a medication used to treat certain blood disorders by reducing symptoms such as enlarged spleen. It may be used alone or in combination with panobinostat, which helps manage certain cancers by slowing cancer cell growth; siremadlin, which targets specific pathways used by cancer cells; and rineterkib, which interferes with cancer cell multiplication. All medications are administered orally in the form of capsules or tablets.
Summary
These two clinical trials represent different approaches to managing complications after transplantation procedures. The first trial, conducted in the Netherlands, specifically focuses on elderly kidney transplant recipients and explores whether simplifying medication regimens can reduce infection risks while maintaining effective organ protection. The second trial, conducted across multiple European countries including Sweden, Poland, Germany, and Italy, takes a different approach by evaluating the long-term safety of continuing treatments in patients who have already shown benefit from medications like ruxolitinib in previous studies.
A notable observation is the geographic concentration of the second trial across multiple European countries, suggesting a collaborative international effort to gather comprehensive long-term safety data. Both trials share a common theme of optimizing treatment strategies to improve patient outcomes while managing potential side effects, though they address different patient populations and medical conditions. The trials demonstrate ongoing efforts to refine medication approaches in transplant medicine and related conditions.
