Ongoing Clinical Trials for Renal Failure
Currently, there are 7 ongoing clinical trials focused on renal failure. These studies are investigating various approaches to improve outcomes for patients with kidney disease, including treatments to protect kidney function, prevent rejection after transplantation, reduce infections in dialysis patients, and manage related complications. The trials are being conducted across several European countries including the Netherlands, Germany, Belgium, Spain, France, Denmark, and Czechia.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- France
- Study on Everolimus for Preventing Rejection in Adult Kidney Transplant Patients
- Study on Optimal Dose of Rabbit Anti-Human T-Lymphocyte Immunoglobulin and Mycophenolic Acid for Kidney Transplant Patients with Low Immunological Risk
- Study Comparing Anakinra and Prednisone for Treating Gout Flare in Patients with Advanced Kidney Disease or Kidney Transplant
- Germany
- Netherlands
- Spain
Study on Dapagliflozin for Patients with Severe Chronic Kidney Disease to Improve Kidney and Heart Health Outcomes
This study is investigating whether dapagliflozin can help patients with severe chronic kidney disease (CKD) by improving both kidney and heart health outcomes. The research includes patients with advanced CKD, those on dialysis, and kidney transplant recipients.
Who can participate: The study welcomes adults aged 18 or older who have advanced CKD with an estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73m² or less, or patients on dialysis with residual urine output of 500 mL or more per day, or kidney transplant recipients with an eGFR of 45 or less. Pre-dialysis patients must be on a stable dose of ACE inhibitors or ARBs for at least four weeks before screening, unless these medications cannot be tolerated.
Who cannot participate: Patients with severe allergies to the study medication, those currently in another clinical trial, pregnant or breastfeeding women, individuals with recent heart attack or stroke, uncontrolled high blood pressure, serious infections requiring treatment, history of cancer within the last five years (except certain skin cancers), or mental health conditions that could interfere with following study instructions cannot participate.
Study focus: The trial aims to determine if dapagliflozin is more effective than placebo in reducing the risk of kidney failure, hospitalization due to heart failure, and death from any cause. Participants will take the medication orally as a film-coated tablet for up to 48 weeks, with regular monitoring throughout the study period.
Investigational drug: Dapagliflozin is an SGLT2 inhibitor that works by affecting how the kidneys handle glucose and has protective effects on both kidneys and heart. The medication is being evaluated for its potential to improve quality of life for people with severe chronic kidney disease.
Study on Everolimus for Preventing Rejection in Adult Kidney Transplant Patients
This trial focuses on kidney transplant patients experiencing a specific type of rejection involving natural killer cells, which are part of the immune system. The study is testing whether everolimus can prevent the transplanted kidney from losing its ability to function properly.
Who can participate: Adult kidney transplant patients who have specific biopsy findings showing inflammation in the small blood vessels of the kidney with moderate chronic damage are eligible. Participants must be on at least dual immunosuppressive therapy, including medications like tacrolimus or cyclosporine along with mycophenolic acid or azathioprine. Patients must also be affiliated with a social insurance program and use effective contraception if applicable.
Who cannot participate: Individuals who have not had a kidney transplant, those not experiencing NK-mediated rejection, patients under 18 or over 65 years old, and those considered part of a vulnerable population cannot participate.
Study focus: The study evaluates whether everolimus can maintain kidney function over six months by monitoring the relative variation in Glomerular Filtration Rate (GFR). Secondary evaluations include assessments of inflammation, chronic lesions, NK cell activity, and proteinuria/creatininuria ratio.
Investigational drug: Everolimus (brand name CERTICAN) is an immunosuppressant that works by inhibiting the mTOR protein, which plays a crucial role in cell growth and proliferation. This action helps suppress the immune response that can lead to organ rejection.
Study on Optimal Dose of Rabbit Anti-Human T-Lymphocyte Immunoglobulin and Mycophenolic Acid for Kidney Transplant Patients with Low Immunological Risk
This research is focused on finding the optimal dose of rabbit anti-human T-lymphocyte immunoglobulin (Grafalon) for kidney transplant patients with low immunological risk to prevent complications related to low levels of CD4 T cells.
Who can participate: Adults aged 18 or older who are receiving their first kidney transplant are eligible. Both men and women can participate, and participants should not be from vulnerable populations.
Who cannot participate: Patients who have previously had a kidney transplant or those with existing kidney failure or poor kidney function are excluded.
Study focus: The trial aims to determine the best dose of Grafalon that can prevent complications without causing prolonged low levels of immune cells. The primary outcome is measured by the relative depletion of T cells by more than 30% compared to baseline at the end of treatment on Day 4. The study includes monitoring for adverse events, drug-related issues, and regular assessments of immune cell counts and kidney function up to one year after transplantation.
Investigational drug: Grafalon is administered intravenously and works by targeting T-lymphocytes, a type of white blood cell involved in immune responses, thereby reducing the risk of transplant rejection.
Study on Preventing Blood Infections in Hemodialysis Patients Using Amoxicillin/Clavulanic Acid or Clindamycin
This study investigates whether prophylactic antibiotic treatment can prevent blood infections in patients with end-stage kidney disease who are undergoing hemodialysis through a central venous catheter (CVC).
Who can participate: Patients with end-stage kidney disease who are receiving hemodialysis through a central venous catheter are eligible. Both men and women of all ages can participate.
Who cannot participate: Patients not undergoing hemodialysis, those without a CVC for vascular access, patients outside the specified age range, vulnerable populations, and patients intolerant to beta-lactam antibiotics are excluded.
Study focus: The trial tests two antibiotics—amoxicillin/clavulanic acid and clindamycin—to see if they can reduce the risk of blood infections during the first six months after starting hemodialysis. Participants will be randomly assigned to receive either antibiotic treatment or placebo, with monitoring for any signs of blood poisoning or severe infections. The primary focus is on reducing hospitalizations due to blood poisoning or infections lasting three or more days.
Investigational drugs: Amoxicillin/clavulanic acid is taken orally as film-coated tablets and works by inhibiting bacterial cell wall synthesis while enhancing effectiveness against bacteria that produce beta-lactamase enzymes. Clindamycin, provided as hard capsules, serves as an alternative for patients intolerant to beta-lactam antibiotics and works by inhibiting bacterial protein synthesis.
Study Comparing Anakinra and Prednisone for Treating Gout Flare in Patients with Advanced Kidney Disease or Kidney Transplant
This trial compares two treatments—anakinra and prednisone—for managing gout flare-ups in patients with chronic kidney disease at stages 3b, 4, or 5, or those who have undergone kidney transplantation.
Who can participate: Adults over 18 years old with confirmed gout attacks (verified by finding urate crystals, ultrasound findings, or meeting Nijmegen criteria with a score greater than 8 out of 13) are eligible. Participants must have persistent gout attacks with a pain score greater than 4 out of 10 and must have chronic kidney disease stages 3b, 4, or 5, have had a kidney transplant, or be on dialysis. Participants must be affiliated with the French social security system and sign informed consent. Premenopausal women must have a negative pregnancy test and use effective contraception.
Who cannot participate: Patients under 18, those without the specified stages of kidney disease, patients who have not had a kidney transplant or are not on dialysis, and those without an untreated gout attack cannot participate.
Study focus: The study evaluates whether anakinra is more effective than prednisone in treating gout attacks by measuring changes in pain levels from the start of treatment to three days after initiation. Secondary evaluations include the speed of resolution of gout attacks, treatment response time, and any relapses during the study period.
Investigational drugs: Anakinra is given as a subcutaneous injection and works by blocking interleukin-1, a protein involved in causing inflammation, thereby reducing swelling and discomfort. Prednisone is a steroid taken orally as tablets that helps reduce inflammation and suppress the immune system to manage gout symptoms.
Study of RMC-035 to prevent kidney injury in patients undergoing open-chest heart surgery
This study evaluates a new medication called RMC-035 (also known as ROSgard) for protecting kidney function in patients at high risk of developing kidney problems after open-chest cardiac surgery.
Who can participate: Adults between 18 and 84 years old who are scheduled for planned (non-emergency) heart surgery with cardiopulmonary bypass are eligible. Participants must have adequate kidney function with eGFR of at least 30 ml/min/1.73m² and specific risk factors for kidney problems, such as reduced kidney function, combined surgeries, or single surgery with at least two additional risk factors like heart problems, diabetes, age over 70, previous heart surgery, anemia, or previous kidney problems. Women must not be pregnant or breastfeeding and must use effective birth control if able to become pregnant. Both men and women must agree to appropriate contraceptive measures.
Who cannot participate: Individuals under 18 or over 85, those with known severe allergic reactions to medications, current participation in other clinical trials, chronic kidney disease, pregnancy or breastfeeding, uncontrolled high blood pressure, recent heart attack, active infection or fever, blood clotting disorders, history of organ transplantation, severe liver disease, autoimmune diseases, active cancer or ongoing cancer treatment, inability to provide informed consent, or severe mental health conditions cannot participate.
Study focus: The trial tests different doses of RMC-035 compared to placebo to find the most effective amount for protecting kidney function. Participants receive either RMC-035 or placebo through an infusion into their veins, with a maximum daily dose of 120 milligrams for up to 2 days. The main assessment of kidney function occurs 90 days after surgery.
Investigational drug: RMC-035 is a biological product containing a modified version of a protein naturally found in the body, designed to reduce the risk of kidney injury during and after heart surgery and help maintain proper kidney function.
Study on Reducing Tacrolimus Dose in Kidney Transplant Patients Using LCPT Compared to Tacrolimus-ER
This trial examines whether the dose of a medication called Envarsus (LCPT form of tacrolimus) can be reduced compared to Advagraf (Tacrolimus-ER) while maintaining effective levels in kidney transplant patients.
Who can participate: Adults between 18 and 70 years old who are at least six months to five years after their first kidney transplant and have stable kidney function are eligible. Participants must have therapeutic tacrolimus concentrations between 4-9 ng/L and have been on a stable dose of extended-release tacrolimus for the last month. They must have a C/D ratio of less than 1.05 ng/mL×1/mg and provide written informed consent. Those who can have children must agree to use highly effective contraception during the study.
Who cannot participate: Patients with kidney failure who need a kidney transplant are excluded.
Study focus: The study determines if switching to LCPT results in a lower pill burden, fewer side effects, and more consistent medication levels in the body. Regular monitoring of tacrolimus levels occurs to ensure they remain within the therapeutic range, with adjustments made as necessary. The trial also explores whether genetic factors like the CYP3A5*1 allele should be considered when prescribing these medications.
Investigational drugs: LCPT (Envarsus) and Tacrolimus-ER (Advagraf) are both prolonged-release forms of tacrolimus, an immunosuppressant that prevents organ rejection in transplant patients by suppressing the immune system. These extended-release versions provide more convenient dosing schedules while maintaining therapeutic effectiveness.
Summary
These seven ongoing clinical trials represent a comprehensive approach to addressing various challenges faced by patients with renal failure. The studies span multiple areas of care, from protecting kidney function in patients with severe chronic kidney disease to managing complications after kidney transplantation and cardiac surgery.
A notable concentration of trials is occurring in France, which hosts three studies focused on kidney transplant-related complications. The research in France covers preventing rejection, optimizing immunosuppressant dosing, and managing gout flares in transplant recipients. Multiple countries including Germany, Spain, Netherlands, and Belgium are participating in the dapagliflozin study, reflecting international collaboration in testing this SGLT2 inhibitor for severe CKD.
The trials investigate diverse therapeutic approaches, including immunosuppressants (everolimus, tacrolimus, Grafalon), anti-inflammatory medications (anakinra, prednisone), prophylactic antibiotics (amoxicillin/clavulanic acid, clindamycin), kidney-protective agents (dapagliflozin, RMC-035), and various dosing strategies for established transplant medications. Several studies focus specifically on kidney transplant patients, addressing both immediate post-transplant complications and long-term management strategies.
These trials collectively aim to improve outcomes for patients at different stages of kidney disease, from those with advanced CKD to those who have received transplants, and even those undergoing cardiac surgery who are at risk for kidney injury. The expected completion dates range from 2025 to 2027, and the findings from these studies may significantly influence future treatment protocols for patients with renal failure.
