Ongoing Clinical Trials Related to Peritoneal Dialysis
Peritoneal dialysis is a treatment for kidney failure that uses the lining of the abdomen to filter waste from the blood. Currently, there are 4 ongoing clinical trials investigating various medications and treatments for patients undergoing this procedure, particularly those with additional conditions such as heart rhythm disorders, end-stage kidney disease, and heart failure. These studies are being conducted across Europe, including in Austria, Denmark, France, and Spain.
Clinical trial locations
- Austria
- Denmark
- France
- Spain
Study on the Safety and Effectiveness of Apixaban and Warfarin for Patients with End-Stage Renal Disease on Peritoneal Dialysis and Atrial Fibrillation
This trial, conducted in France, is comparing two blood-thinning medications, apixaban and warfarin, in patients who have both non-valvular atrial fibrillation and end-stage kidney disease requiring treatment. The study’s main focus is to evaluate which medication is safer by monitoring bleeding events over a 12-month period.
Who can join: Adults aged 18 or older who have been on peritoneal dialysis for at least 3 months and have a history of non-valvular atrial fibrillation are eligible. Participants must have a CHA2DS2-VASc score of 2 or higher, which helps estimate stroke risk in people with irregular heartbeats. Women of childbearing potential must use effective birth control.
Who cannot join: Patients not receiving chronic peritoneal dialysis or those without non-valvular atrial fibrillation are excluded from participation.
Study goals: The trial aims to determine the safety and effectiveness of apixaban compared to warfarin, particularly focusing on the occurrence of bleeding events. Researchers will also monitor for stroke, heart attack, and other health complications. Both medications help prevent blood clots, but they work through different mechanisms in the body.
Medications being tested: Apixaban works by blocking certain proteins involved in blood clotting, while warfarin decreases the blood’s clotting ability by inhibiting vitamin K-dependent clotting factors. Both are taken as oral tablets.
Study on the Safety and Effectiveness of Warfarin for Patients with Atrial Fibrillation Undergoing Dialysis
This Danish study is examining warfarin in patients with atrial fibrillation who are undergoing dialysis for end-stage kidney disease. The trial compares patients taking warfarin with those receiving no treatment to assess differences in stroke occurrence and bleeding risk.
Who can join: Adults at least 18 years old on chronic dialysis with a new diagnosis of non-valvular atrial fibrillation, or those who have had the condition for more than 2 months without treatment, are eligible. The atrial fibrillation must be confirmed by an electrocardiogram or heart monitoring device showing episodes lasting at least 30 seconds.
Who cannot join: Patients with end-stage kidney disease who already have atrial fibrillation are excluded from this particular study.
Study goals: The research aims to understand whether warfarin can effectively prevent strokes and complications in dialysis patients without causing excessive bleeding. This information will help doctors make better treatment decisions for patients with both conditions.
Medication being tested: Warfarin is an established anticoagulant that prevents blood clots by inhibiting vitamin K, which is necessary for forming clotting factors in the blood. It is administered as an oral tablet with dosing adjusted based on regular blood tests.
Study on Cefepime for Patients with Chronic Kidney Disease on Peritoneal Dialysis Without Peritonitis
This Austrian trial is investigating the antibiotic cefepime in patients with stage 5 chronic kidney disease undergoing automated peritoneal dialysis. The study focuses on patients without peritonitis, which is an infection of the abdominal lining.
Who can join: Adults over 18 years old who have been on an automated peritoneal dialysis regime for at least one month are eligible. Participants must be using specific glucose-based dialysis fluids or icodextrin and must be willing to follow the study procedures.
Who cannot join: Patients not undergoing peritoneal dialysis, those without stage 5 chronic kidney disease, or individuals outside the specified age range cannot participate.
Study goals: The trial aims to determine if cefepime, when administered directly into the abdominal cavity through cycler-therapy, reaches adequate concentrations in both blood and dialysis fluid to be effective. Researchers are examining how the drug is absorbed, distributed, and eliminated from the body to assess its effectiveness with this specific method of administration.
Medication being tested: Cefepime is a fourth-generation cephalosporin antibiotic that kills bacteria by inhibiting cell wall synthesis. It is given as a solution for injection or infusion directly into the abdominal cavity.
Study on the Effects of Intraperitoneal Furosemide in Patients with Heart Failure on Peritoneal Dialysis
This Spanish study is comparing two methods of administering furosemide in patients with heart failure who are on peritoneal dialysis: directly into the abdominal cavity versus oral administration. The trial will assess effects on fluid levels and overall hydration status.
Who can join: Adults over 18 years old who are clinically stable on peritoneal dialysis and taking at least 120 mg of oral furosemide daily for the past 15 days are eligible. Participants must have a properly functioning dialysis catheter, produce more than 500 ml of urine per day, and have completed a peritoneal equilibrium test within the last three months.
Who cannot join: Patients who are not stable in their current health condition, not receiving treatment in a peritoneal dialysis unit, or outside the specified age range are excluded.
Study goals: The trial aims to evaluate how intraperitoneal furosemide affects body fluid levels compared to oral administration. Researchers will monitor body weight, blood pressure, swelling, and use advanced techniques like ultrasound and bioimpedance to assess fluid levels. The study will also measure biochemical markers that indicate fluid congestion in the body.
Medication being tested: Furosemide is a loop diuretic that helps remove excess fluid from the body by inhibiting sodium and chloride reabsorption in the kidneys, leading to increased urine production. The study will run for up to 30 days.
Summary
These four clinical trials represent diverse research efforts across Europe to improve treatment options for patients undergoing peritoneal dialysis. Two studies focus on managing atrial fibrillation with anticoagulant medications, comparing different approaches to preventing blood clots while minimizing bleeding risks. Another trial investigates an antibiotic’s effectiveness when administered directly into the abdominal cavity, while the fourth examines a novel way to manage fluid retention in heart failure patients.
Geographically, the trials are distributed across four European countries, with each country hosting one study. Notably, two trials focus on anticoagulation therapy, reflecting the significant concern about managing irregular heart rhythms in patients with kidney failure. The research encompasses both well-established medications like warfarin and newer approaches such as intraperitoneal drug administration, demonstrating efforts to optimize both traditional and innovative treatment methods for this patient population.
