Ongoing Clinical Trials for Patients Undergoing Haemodialysis

There are currently 5 clinical trials investigating various treatments for patients undergoing haemodialysis, focusing on blood clot prevention, immune suppression, and infection management. These studies are taking place in France and Denmark, testing medications including rivaroxaban, tacrolimus, warfarin, medium-chain triglycerides, and cefazolin to improve outcomes for people receiving dialysis treatment.

Clinical trial locations

• Denmark
  • Study on the Safety and Effectiveness of Warfarin for Patients with Atrial Fibrillation Undergoing Dialysis
• France
  • Study of Cefazolin for Patients on Chronic Hemodialysis with Infections
  • A study comparing medium-chain triglycerides and sodium chloride infusions during hemodialysis to improve toxin removal in patients with chronic kidney disease
  • Study on Rivaroxaban for Patients with End-Stage Renal Disease on Hemodialysis
  • Study on the Effects of Tacrolimus on Blood Sugar Levels in Patients Undergoing Dialysis Before Kidney Transplantation

Study on Rivaroxaban for Patients with End-Stage Renal Disease on Hemodialysis

This trial is investigating the blood-thinning medication rivaroxaban in patients with end-stage kidney disease who are receiving chronic dialysis treatment. The study aims to identify the safest and most effective dose for these patients.

Inclusion criteria: To participate, you must be at least 18 years old and have been receiving chronic dialysis for at least three months. You must also be covered by social security and willing to sign an informed consent form.

Exclusion criteria: You cannot participate if you are not on chronic dialysis, if you have a medical reason requiring blood-thinning medication, or if you belong to a vulnerable population.

Study focus: The trial will test three different daily doses of rivaroxaban: 5 mg, 10 mg, and 15 mg. Researchers will carefully monitor how your body processes the medication and watch for any bleeding events. The goal is to find the dose that best prevents blood clots while minimizing bleeding risks. The study is scheduled to run from April 2024 to April 2025.

Investigational drug: Rivaroxaban is an anticoagulant medication that helps prevent dangerous blood clots by blocking a specific clotting factor in your blood called Factor Xa.

Study on the Effects of Tacrolimus on Blood Sugar Levels in Patients Undergoing Dialysis Before Kidney Transplantation

This 14-day study examines how the immunosuppressive medication tacrolimus affects blood sugar levels in dialysis patients who are awaiting kidney transplantation.

Inclusion criteria: You must be 18 years or older, currently receiving dialysis at a participating center, and eligible for a kidney transplant at Nantes University Hospital. You must be able to understand the study plan and provide informed consent, and you must have social security coverage.

Exclusion criteria: You cannot participate if you are not undergoing dialysis, are outside the specified age range, or belong to a vulnerable population.

Study focus: The trial will measure changes in your blood sugar levels before and after 14 days of taking tacrolimus. Researchers want to understand how this medication, which is commonly used after transplant to prevent organ rejection, affects the way your body processes carbohydrates while you are still on dialysis.

Investigational drug: Tacrolimus is an immunosuppressant that works by reducing the activity of your immune system. It is taken orally and helps prevent the body from rejecting transplanted organs.

Study on the Safety and Effectiveness of Warfarin for Patients with Atrial Fibrillation Undergoing Dialysis

This trial is investigating whether warfarin, a commonly used blood thinner, is safe and effective for patients who have both an irregular heartbeat (atrial fibrillation) and end-stage kidney disease requiring dialysis.

Inclusion criteria: You must be at least 18 years old and receiving chronic dialysis. You should have either a new diagnosis of non-valvular atrial fibrillation or have had it for more than two months without treatment. The irregular heartbeat must be confirmed by an electrocardiogram or other heart monitoring device. Both men and women can participate.

Exclusion criteria: The trial documentation indicates specific exclusions related to end-stage kidney disease and atrial fibrillation status, which will be evaluated by the study team.

Study focus: The study will compare patients taking warfarin with those receiving no treatment to see if there are differences in serious events like strokes or mini-strokes. Researchers will also closely monitor for major bleeding, which is a known risk with blood-thinning medications. This information will help doctors understand the best ways to prevent strokes in dialysis patients with irregular heartbeats.

Investigational drug: Warfarin is an oral anticoagulant that prevents blood clots by interfering with vitamin K, which is needed for blood clotting. It has been used for many years to prevent strokes in patients with atrial fibrillation.

A study comparing medium-chain triglycerides and sodium chloride infusions during hemodialysis to improve toxin removal in patients with chronic kidney disease

This trial is testing a new approach to improve the removal of harmful substances from the blood during dialysis treatment, specifically targeting toxins that are difficult to remove with standard dialysis.

Inclusion criteria: You must be 18 years or older and have been receiving dialysis three times per week for at least three months, with each session lasting four hours. You must produce virtually no urine (less than 100 mL per day). Women of childbearing age must use effective contraception and undergo a pregnancy test. You must be enrolled in a social security program and able to provide written consent.

Exclusion criteria: You cannot participate if you have been on dialysis for less than three months, produce more than 100 mL of urine per day, are under 18 years old, are pregnant or breastfeeding, have allergies to medium-chain fatty acids, or have severe heart, liver, or blood disorders.

Study focus: The study compares two treatments during your regular four-hour dialysis sessions. One approach uses Medialipide, a special fat-based solution, while the other uses standard saline (salt water). Researchers will measure how well each method removes a stubborn toxin called p-cresyl sulfate from your blood. Blood samples will be taken throughout the session to assess effectiveness and safety.

Investigational drugs: Medialipide is a medium-chain fatty acid solution that may help separate toxins from proteins in the blood, making them easier to remove during dialysis. The comparison treatment is standard saline solution.

Study of Cefazolin for Patients on Chronic Hemodialysis with Infections

This study focuses on understanding how the antibiotic cefazolin works in patients receiving long-term dialysis treatment who develop bacterial infections.

Inclusion criteria: You must be 18 years or older and receiving chronic intermittent dialysis. You must need cefazolin to treat a suspected or confirmed bacterial infection, particularly certain types of staph or blood infections. Blood samples must be obtainable from your arm or dialysis machine until your next dialysis session 48 hours later. You must be covered by social security and sign an informed consent form.

Exclusion criteria: You cannot participate if you are not on chronic dialysis, do not have an infection, are outside the specified age range, or belong to a vulnerable population.

Study focus: The trial will monitor how long cefazolin stays at effective levels in your bloodstream between dialysis sessions. Researchers will assess how well the antibiotic treats your infection at one week and again at six weeks after starting treatment. The study will also watch for any side effects for up to six weeks after your last dose. This information will help doctors determine the best dosing schedule for cefazolin in dialysis patients.

Investigational drug: Cefazolin is a first-generation cephalosporin antibiotic given by injection. It works by breaking down bacterial cell walls, effectively killing the bacteria causing your infection.

Summary

These five clinical trials represent diverse approaches to improving care for patients undergoing dialysis. Four of the five trials are being conducted in France, with one trial in Denmark, suggesting a strong research focus on dialysis-related complications in these European countries.

The studies address several important health concerns for dialysis patients: preventing blood clots and strokes with anticoagulants (rivaroxaban and warfarin), managing blood sugar levels before transplantation (tacrolimus), improving toxin removal during dialysis (medium-chain triglycerides), and treating infections more effectively (cefazolin). This variety reflects the complex medical needs of people receiving dialysis treatment.

Most trials have specific requirements regarding how long you have been on dialysis and whether you produce any urine, as these factors can affect how medications work in your body. If you are interested in participating, discuss these opportunities with your dialysis care team to determine which trials might be appropriate for your situation.