European Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport...
Alport SyndromeHereditary Kidney Disease3 moreThe hereditary type IV collagen disease Alport syndrome inevitably leads to end-stage renal disease. Currently there are no therapies known to improve outcome. Our non-interventional, observational study investigates, if medications such as ACE-inhibitors can (1) delay time to dialysis and (2) improve life-expectancy within three generations of Alport-families in Europe.
Product Surveillance Registry
Cardiac Rhythm DisordersUrological Disorders17 moreThe purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
Chinese Cohort Study of Chronic Kidney Disease
Renal InsufficiencyChronicThis study aimed to explore underlying mechanisms of chronic kidney disease progression and its association with adverse consequences. It will enroll approximately 5000 pre-dialysis chronic kidney disease patients aged between 18 and 74 years in mainland China and follow-up for at least 5 years. Questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected at baseline and annually. The principal clinical outcomes of the study consist of renal disease events, cardiovascular events, and death.
Hemofilter Life Span, ECLS and/or CRRT
Kidney DiseasesAcute Injury of Kidney3 moreThe goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Little is known about the effects of CRRT in this particular population and improved knowledge will be useful clinically and may lead to novel therapeutic approaches and improved outcomes for these critically ill patients.
Nanoparticle for DSA Removal
Kidney FailurePresence of Donor Specific AntibodiesMagnetic nanoparticles, coated with human leukocyte antigens (HLA) to capture anti-HLA antibodies with donor specificity (donor-specific antibodies, DSA), will be tested ex-vivo.
A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone...
Multiple MyelomaRenal Impairment7 moreThis is an Investigator-Initiated, phase 2, prospective, open-label study designed to be conducted in six hospitals in Greece. Eligible patients will initially receive an induction phase of six 28-day cycles of isatuximab in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd), followed by a maintenance phase with isatuximab and lenalidomide until disease progression, death, unacceptable adverse events, lost to follow up, or consent withdrawal, whichever occurs first. The study will last for approximately 36 months (follow-up period), starting from the date of the first patient in, to the date of the last patient last visit. The primary objective is to assess the effect of induction treatment with isatuximab in combination with VCd on the renal function of newly diagnosed patients with multiple myeloma and severe renal impairment (RI). The secondary objectives are to evaluate the effect of isatuximab in combination with VCd, followed by lenalidomide maintenance on: Overall response rate, Progression-Free Survival, Time to Response, Duration of Response, Overall Survival, Minimal Residual Disease negativity rate, Safety
Emotion and Cognitive Function and Brain Imaging Change in HD Patients
Kidney FailureChronic2 moreObserve the influence of entering hemodialysis treatment on the emotional and cognitive functions of ESRD patients. Observe the influence of entering hemodialysis treatment on the brain structure imaging of ESRD patients. Analyze and study the relevant clinical risk factors of the above-mentioned effects, and find targets for therapeutic intervention.
Effects of Bioelectric Stimulation in Patients With Non-Dialysis Dependent Chronic Kidney Disease...
Renal InsufficiencyChronic1 moreChronic kidney disease (CKD) consists of kidney damage, with a consequent progressive and irreversible loss of kidney function. In the early stages of the disease, there is already a reduction in circulating levels of α-klotho protein, which is related to worsening renal function. Therapeutic strategies that increase serum α-klotho levels can be of great value in the treatment of CKD. Electrical stimulation contributes to the reduction of reactive oxygen species, DNA damage and improves the efficiency rate of dialysis, suggesting a systemic effect in patients with end-stage CKD. The aim of this study is to evaluate the effects of bioelectric stimulation on renal function and physical capacity in patients with CKD. For this, patients will be randomized into bioelectric stimulation or a control group. Bioelectric stimulation will be performed three times a week for eight weeks. The control group will only be evaluated and re-evaluated. The following pre-and post-intervention assessments will be performed: analysis of the plasma content of α-Klotho and soluble creatinine to assess renal function, six-minute walk test to assess functional capacity; dosage of interleukins and tumor necrosis factor to analyze the inflammatory profile; sit and stand test with 10 repetitions and load cell dynamometry to assess lower limb muscle strength and application of the EuroQoL-5D questionnaire for quality of life. Biochemical analyzes for renal function and inflammatory profile will also be performed after four weeks of follow-up.
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function...
Chronic Kidney DiseaseThis is a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy subjects, and to provide a basis for dose selection of HRS-1780 in patients with chronic kidney disease.
A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects With Severe Renal Impairment and Normal...
Renal ImpairmentThis will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.