
NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins
Chronic Kidney DiseasesHealthyThe objective of the pilot study is to validate the clinical use of an innovative symbiotic in patients with chronic kidney disease (CKD) stage 3b-4 and in healthy subjects. The study aims at evaluating the effects of a symbiotic, consisting of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructooligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins), by achieving two objectives: Reduction of the serum levels of microbiota-derived uremic toxins, involved in a variety of cardiovascular complications in CKD Reduction of intestinal permeability, inflammatory markers and oxidative stress

RENACTIF: Reduction of the Thrombotic Phenotype in Renal Insufficiency With N-AcetylCysteine
Chronic Kidney DiseasesChronic Kidney Disease (CKD) is a known risk factor of cardiovascular morbidity and mortality. In CKD, decline of renal function results in the accumulation of uremic toxins in blood and tissue, such as Indoxyl Sulfate (IS). IS plasma level is predictive of mortality and cardiovascular disease (CVD). Patients with CKD have increased oxidative stress and circulating tissue factor (TF) levels. In vitro, IS induces an inflammatory, pro-oxidative and pro-coagulant phenotype on endothelial cells and activates TF. N-acetylcysteine (NAC) protects endothelial cells from the effects of IS. NAC reduces oxidative stress and production of activated TF. A prospective study evaluating an oral NAC treatment versus placebo in chronic hemodialysis patients showed a better cardiovascular outcome but the physiopathology was unclear. The hypothesis is that NAC reduces cardiovascular risk by its effect on uremic toxin-induced pro-coagulant TF production. The primary objective is to compare the effect of NAC intravenously administered at each dialysis session (2gram on 3 dialysis sessions per week) to placebo on circulating TF levels in patients with CKD on chronic hemodialysis after 4 weeks of treatment. The objective is to show a 33% decrease in circulating tissue factor (TF) levels in the NAC group compared to the control group. It is a randomized, double-blind, placebo-controlled crossover trial that includes chronic hemodialysis patients from La Conception Hospital (AP-HM) in Marseilles, France. This is an interventional biomedical research project. 20 patients will be included in each group and will receive during 4 weeks intravenous injection. This study will give a pathophysiological rationale for the use of NAC to reduce thrombotic and cardiovascular risk in patients with CKD. This step will provide the rationale for a clinical trial to reduce the occurrence of major cardiovascular events with IV NAC in hemodialysis (HD) patients.

Safety and Effectiveness of Propagermanium in Diabetic Kidney Disease Participants Receiving Irbesartan...
Diabetic Kidney DiseaseThis study will be evaluating the safety and efficacy of propagermanium for the treatment of participants with DKD who are already taking irbesartan by: monitoring symptoms that participants may experience while on the study, measuring levels of protein in participant's urine and kidney function during the course of the study, measuring the levels of propagermanium and irbesartan that enters into participant's urine and blood, and comparing the propagermanium outcomes to participants' pre-study and placebo outcomes. Eligible participants will randomly be assigned to one of two arms to receive both the propagermanium and placebo in different orders as follows, either: Treatment Period 1 taking a propagermanium capsule twice a day for 12 weeks, followed by a six week washout period followed by Treatment Period 2 taking a placebo capsule twice a day for 12 weeks. OR Treatment Period 1 taking a placebo capsule twice a day for 12 weeks, followed by a six week washout period followed by Treatment Period 2 taking a propagermanium capsule twice a day for 12 weeks.

Percutaneous Nephroscopic Treatment of Parapelvic Cysts
Kidney StoneParapelvic Cyst2 moreBackground of the project: The surgical treatment of parapelvic cysts is currently less researched and there is no gold standard for surgery. Previously, in percutaneous nephrolithotomy, we found that fenestration and fenestration drainage in the simultaneous treatment of pararenal pelvis cysts under nephroscopic nephroscopic surgery has clear curative effect, less trauma, and quicker recovery. Objective: To clarify the safety, efficacy and long-term efficacy of percutaneous nephroscopy in the treatment of parapelvic cysts. Nature: Retrospective case cohort study. Basic research process: Retrospective collection of cases in our hospital who underwent percutaneous nephroscopy for the treatment of parapelvic cysts, and comparison of preoperative and postoperative cyst size changes and long-term efficacy.

Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis...
Vascular DiseasesKidney DiseasesBackground Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. There is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes. Methods This study was conducted as a prospective 1:1 randomized single centre clinical trial. Participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct primary dilatation, with either a standard balloon or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. Secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.

Desidustat in the Treatment of Chemotherapy Induced Anemia
Anemia of Chronic Kidney DiseaseChemotherapy EffectThis is a Phase 1, Open-label, Single Dose, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Desidustat for treatment of anemia in patients receiving chemotherapy.

Plazomicin Study in ESRD Patients Receiving IHD
End Stage Renal DiseaseThis study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing recommendations for patients with ESRD receiving IHD.

Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia
Chronic Kidney Disease Requiring Chronic DialysisThe current study will investigate whether long term implementation of expanded hemodialysis (HDx) will effectively decrease serum levels of large uremic toxins and ameliorate progression of sarcopenia in patients with chronic kidney disease requiring hemodialysis.

Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing...
Chronic Kidney DiseaseInflammation1 moreThe purpose of this research study is to compare the safety and effectiveness of 2 different doses of a study drug called ziltivekimab to placebo (an inactive substance) in reducing inflammation and improving some of the bad effects of inflammation on heart disease. Participants will be randomly (by chance) assigned to receive either ziltivekimab or placebo. The chance that participants will be assigned into one of the three study arms of ziltivekimab (either 15 mg or 30 mg) or placebo is the same (approximately 33%). This is a double-blind study, which means neither participants nor the study doctor will know which group the participants are in. In case of an emergency, however, the study doctor can get this information. The study drug will be injected under the skin once every 4 weeks. In this study participants will receive 3 injections of study drug. The total study duration for each participant will be approximately 6 months.

Effects of a Mindfulness-based Intervention in Stress, Pain and Quality of Life in People Undergoing...
Renal InsufficiencyChronic7 moreThis project has as main objective to evaluate the effects of a Mindfulness-based intervention (MBI) in the reduction of stressors, pain and quality of life of people with chronic kidney disease undergoing hemodialysis (HD). The investigators hypothesize that this program offered during hemodialysis sessions may modify the pain profile, stressors levels and may improve the quality of life by the people in hemodialysis. This is an incipient field of research at the international level and almost nonexistent in Brazil. Evidence indicates the need for MBIs to be performed during HD sessions, adapted to the context, to facilitate patient compliance, contribute to the management of the discomfort generated during HD and promote health.