Ongoing Clinical Trials for End-Stage Renal Disease
End-stage renal disease (ESRD) is a serious condition where the kidneys can no longer function at a level needed for day-to-day life. Currently, 8 clinical trials are exploring new treatments and approaches for managing this condition. These studies investigate immunosuppression strategies for kidney transplant recipients, medications to prevent transplant complications, treatments for patients on dialysis, and therapies for patients with related heart conditions. The trials are being conducted across multiple European countries including Germany, Spain, the Netherlands, France, Italy, Sweden, Poland, Norway, Finland, Iceland, and Denmark.
Clinical trial locations
- Denmark
- Finland
- France
- Germany
- Iceland
- Italy
- Study on the Safety of Glucothera Plus for Children with End-Stage Kidney Disease Undergoing Peritoneal Dialysis
- Study on the Safety and Effectiveness of PolyCore (Xylitol, L-Carnitine, Polydextrin) for Patients with End-Stage Kidney Disease Starting Peritoneal Dialysis
- Study on XyloCore and Drug Combination for Patients with End-Stage Kidney Disease Undergoing Peritoneal Dialysis
- Netherlands
- Norway
- Poland
- Spain
- Sweden
Reduced Immunosuppression Therapy Trial for Elderly Kidney Transplant Recipients with End-Stage Renal Disease
This trial, known as the RELEASE study, examines whether older adults who receive kidney transplants can benefit from reduced doses of immunosuppressive medications. The study is being conducted in Germany and Spain.
Who can participate: You must be 70 years of age or older and receiving your first kidney transplant from either a living or deceased donor. Your blood type must be compatible with the donor kidney, and you must have a cPRA level of 50% or less. The kidney must have been preserved for less than 30 hours since removal from the donor. You must be able to understand and sign an informed consent document, and male participants must agree to use dual barrier contraception.
Who cannot participate: You cannot join if you have severe mental health conditions, a history of cancer in the last 5 years (except certain skin cancers), or have tested positive for HIV, hepatitis B, or hepatitis C. You are also excluded if you have had a previous organ transplant that failed within the first year, are receiving a transplant from a donor after cardiac death, are participating in another clinical trial with experimental treatment, are pregnant or breastfeeding, have an active infection requiring treatment, or have a medical condition that would make participation unsafe.
What the trial examines: The study compares a reduced immunosuppression regimen to the standard treatment approach in elderly kidney transplant recipients. The goal is to determine if lower doses of immunosuppressive medications can be as effective as standard doses while potentially reducing side effects. Participants will be randomly assigned to either the standard or reduced immunosuppression group and followed for 12 months after their transplant.
Medications being tested: The study uses immunosuppressive medications including tacrolimus, prednisone, methylprednisolone, basiliximab, and mycophenolate sodium. These medications help prevent the body from rejecting the transplanted kidney by reducing immune system activity.
Study on Alkaline Phosphatase for Reducing Kidney Transplant Complications in Patients with End-Stage Kidney Disease
This trial investigates whether a treatment called alkaline phosphatase (bRESCAP) can help prevent delayed graft function in patients receiving kidney transplants from donors who have experienced cardiac death. The study is taking place in the Netherlands.
Who can participate: You must be over 18 years old and receiving a kidney from a donor who passed away due to cardiac death while in intensive care (donor cardiac death type III). You must be able to provide written informed consent.
Who cannot participate: You cannot join if you are not receiving a kidney from a donation after circulatory death donor, if you are not within the specified age range, or if you are part of a vulnerable population requiring extra protection.
What the trial examines: The study focuses on ischemia reperfusion injury, which can cause delayed graft function where the transplanted kidney does not work immediately and the patient may need dialysis within the first week after transplant. Participants will receive either bRESCAP or a placebo through an intravenous infusion. The trial will monitor whether the treatment can decrease the need for dialysis and improve kidney function after transplantation.
Medication being tested: Alkaline phosphatase, bovine (bRESCAP) is being tested to see if it can help prevent damage to kidney tissue when blood supply returns after a period of lack of oxygen during transplantation.
Study on Apixaban for Preventing Stroke in Patients with Atrial Fibrillation and Stage 5 Chronic Kidney Disease
This trial examines whether the blood thinner apixaban can help prevent strokes in patients who have both atrial fibrillation (irregular heartbeat) and the most severe stage of kidney disease. The study is conducted across Sweden, Poland, Norway, Finland, Iceland, and the Netherlands.
Who can participate: You must be 18 years or older and receiving ongoing chronic dialysis or have very low kidney function (eGFR less than 20 ml/min/1.73 m² at least twice in the past year). You must have a diagnosis of atrial fibrillation or atrial flutter and a CHA2DS2-VASc score of 2 or more for men, or 3 or more for women. Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study.
Who cannot participate: You cannot join if you have a history of bleeding inside the skull, a high risk of fatal bleeding, are unable to follow study procedures, are pregnant or breastfeeding, or are participating in another clinical trial at the same time.
What the trial examines: The study compares taking apixaban with not taking any anticoagulant medication. The main goal is to determine if apixaban can reduce the risk of ischemic stroke (caused by a blood clot blocking a blood vessel in the brain) or systemic embolism (when a blood clot travels to other parts of the body) without causing serious bleeding.
Medication being tested: Apixaban is an anticoagulant medication taken as a film-coated tablet, 2.5 mg twice daily. It works by blocking a specific protein in the blood involved in clot formation.
Study on Continuing or Stopping Immunosuppressive Therapy with Rituximab in Patients with ANCA Vasculitis and End-stage Kidney Disease
This French trial examines whether patients with ANCA vasculitis (an autoimmune disease affecting blood vessels) who develop kidney failure should continue or stop their immunosuppressive therapy.
Who can participate: You must be between 18 and 90 years old with GPA or MPA AAV involving kidney damage. You must be experiencing your first symptoms or a return of AAV and have kidney failure defined by a glomerular filtration rate of 15 or less, or need dialysis for more than 60 days. You must have kidney failure in your original kidneys, not transplanted ones, and must agree in writing to participate. You must also be part of the French social security system.
Who cannot participate: Specific exclusion criteria for this trial relate to patients not meeting the inclusion requirements.
What the trial examines: The study randomly assigns participants to either continue their current immunosuppressive therapy or stop it. Participants are followed for 24 months to observe severe events such as major relapses, severe infections, or death. The goal is to determine which approach leads to better outcomes.
Medications being tested: The immunosuppressive medications involved include rituximab (injectable solution), azathioprine (oral tablet), prednisolone (oral tablet), mycophenolate mofetil (oral film-coated tablet), and prednisone (oral tablet).
Study on the Safety of Glucothera Plus for Children with End-Stage Kidney Disease Undergoing Peritoneal Dialysis
This Italian trial focuses on evaluating the safety of Glucothera Plus, a solution used for peritoneal dialysis in children with kidney failure.
Who can participate: Your child must be younger than 18 years old with kidney failure and receiving continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for at least six months. The child must have a plasma L-carnitine level of 30 nmol/ml or lower, a specific dwell volume between 800 ml/m² and 1200 ml/m² of body surface, and no peritonitis episodes in the last three months. Written informed consent is required.
Who cannot participate: Children not meeting the inclusion criteria cannot participate.
What the trial examines: The study monitors children receiving Glucothera Plus for any side effects and changes in their health. Regular check-ups include physical examinations, vital signs checks, and blood tests to ensure safety. The trial assesses kidney function, dialysis effectiveness, and quality of life measures.
Solution being tested: Glucothera Plus contains levocarnitine, magnesium chloride hexahydrate, sodium chloride, calcium chloride dihydrate, glucose monohydrate, and sodium lactate. It is administered into the abdominal cavity as part of peritoneal dialysis treatment.
Study on Mannitol and Normal Saline for Patients with End-Stage Renal Disease Undergoing Kidney Transplantation
This Finnish trial compares the use of mannitol with normal saline in patients receiving kidneys from brain-dead donors to see if mannitol can help improve transplant success.
Who can participate: You must be receiving a kidney transplant from an adult brain-dead donor and be between 18 and 64 years old.
Who cannot participate: You cannot join if you have not undergone kidney transplantation, are not within the specified age range, or belong to a vulnerable population.
What the trial examines: The study investigates whether mannitol can help reduce delayed graft function, where the new kidney takes longer than expected to start working properly. Participants receive either mannitol or a placebo through an intravenous infusion. The trial monitors how quickly the transplanted kidney begins to function and looks at kidney rejection and performance at various time points.
Medications being tested: Mannitol is a type of sugar alcohol that may help reduce swelling and improve blood flow to the transplanted kidney. Normal saline is a sterile salt-water mixture used as a comparison treatment.
Study on the Safety and Effectiveness of PolyCore (Xylitol, L-Carnitine, Polydextrin) for Patients with End-Stage Kidney Disease Starting Peritoneal Dialysis
This Italian trial evaluates the safety of PolyCore, a special solution designed for peritoneal dialysis in patients beginning this form of kidney replacement therapy.
Who can participate: You must be an adult with kidney failure, have a GFR of at least 5, and have been receiving peritoneal dialysis for less than 6 months in stable health. You must be on a specific treatment plan using one daily solution based on Icodextrin (7.5%) and one daily solution based on glucose (up to 1.5%). You must have a weekly Kt/V urea of at least 1.7 and agree to participate by giving informed consent.
Who cannot participate: Patients not meeting the inclusion criteria cannot participate.
What the trial examines: The study monitors participants for any side effects and changes in health. Regular check-ups include physical examinations, vital signs measurements, and blood and urine tests. The trial assesses dialysis effectiveness, kidney function, and quality of life measures.
Solution being tested: PolyCore contains levocarnitine, magnesium chloride hexahydrate, sodium chloride, calcium chloride dihydrate, lactic acid, xylitol, and polydextrose. It is administered through the abdominal cavity as part of peritoneal dialysis.
Study on XyloCore and Drug Combination for Patients with End-Stage Kidney Disease Undergoing Peritoneal Dialysis
This international trial, conducted in Italy, Spain, Germany, Denmark, and Sweden, evaluates XyloCore, an experimental solution for peritoneal dialysis that aims to reduce glucose absorption.
Who can participate: You must be 18 years or older with a diagnosis of kidney failure and treated with continuous ambulatory peritoneal dialysis (CAPD) for the last three months. You must be in stable clinical condition with no unexpected hospital stays or major heart events in the past three months, and no peritonitis episodes in the last three months. You must be using Extraneal for at least one month and using 1, 2, or 3 short-dwell exchanges with specific dialysis solutions. Your weekly Kt/V urea measurement must be greater than 1.7. You must understand the study and provide informed consent.
Who cannot participate: You cannot join if you do not have kidney failure, are not within the specified age range, are not willing or able to follow study procedures, have other medical conditions that might interfere with the study, are pregnant or breastfeeding, are participating in another clinical trial, have a history of allergic reactions to study medications, have recently had major surgery, or have a history of substance abuse.
What the trial examines: The study compares the effectiveness and safety of XyloCore with standard glucose-based solutions. Participants undergo regular assessments to monitor dialysis effectiveness, blood sugar and cholesterol levels, kidney function, energy levels, and any side effects. The study aims to determine if XyloCore is as effective as standard treatments.
Solution being tested: XyloCore is a glucose-sparing solution for peritoneal dialysis administered into the abdominal cavity. It is designed to provide an alternative to standard glucose-based dialysis solutions.
Summary
The 8 clinical trials for end-stage renal disease reflect diverse research approaches across Europe. Several trials focus on peritoneal dialysis solutions, particularly in Italy where three studies examine novel dialysis formulations including Glucothera Plus, PolyCore, and XyloCore. These studies aim to improve dialysis safety and effectiveness while reducing complications associated with traditional glucose-based solutions.
Kidney transplantation is another major focus, with trials in Germany, Spain, the Netherlands, and Finland investigating ways to improve transplant outcomes. These include studies on reduced immunosuppression for elderly recipients, medications to prevent delayed graft function, and infusion protocols during transplant surgery.
A multi-country trial spanning six Nordic and Western European countries examines stroke prevention in patients with both atrial fibrillation and severe kidney disease, addressing a significant gap in treatment guidance for this complex patient population.
The geographical distribution shows concentration of research in Western and Southern Europe, with Italy and multi-country collaborations particularly active. The trials address different patient populations, from children requiring dialysis to elderly transplant recipients, reflecting the diverse needs of patients with kidney failure.
