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Renal Insufficiency clinical trials

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NCT ID: NCT06366529 Recruiting - Clinical trials for Renal Insufficiency, Chronic

Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction

Start date: September 1, 2023
Phase:
Study type: Observational

Currently, renal biopsy is the gold standard for evaluating renal pathology and renal fibrosis, but it is invasive and carries the risk of serious complications; and the sampled tissue is only a small part of the kidney, which is prone to sampling bias. The lack of reliable, comprehensive test results has hindered the research of new anti-fibrotic drugs and delayed the clinical application of effective new drugs. Therefore, the development of a non-invasive dynamic detection method for renal insufficiency and renal fibrosis in vivo is an urgent clinical problem to be solved. With the continuous development and update of technology, imaging provides a new way to non-invasively evaluate renal fibrosis. Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis, magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes. Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status, physical properties, and molecular properties of the kidney. In recent years, in the context of precision medicine, artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis. It can extract and learn features in images with high throughput, make greater use of information in medical images that cannot be recognized by the human eye, and achieve disease diagnosis, prognosis assessment, and efficacy prediction by building models. However, most of the current research is in the preliminary stage, and there are still few studies on the assessment of renal insufficiency and renal fibrosis. I believe that with the continuous improvement of algorithms and the optimization of models, the progress of radiomics and machine learning will be great. To a certain extent, it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis.

NCT ID: NCT06354231 Recruiting - Renal Insufficiency Clinical Trials

DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC

Start date: July 20, 2023
Phase: Phase 2
Study type: Interventional

Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment.

NCT ID: NCT06347029 Recruiting - Clinical trials for Chronic Renal Failure

Evaluation of Endothelial Dysfunction Using the "Flow Mediated Dilation" Test in a Population of Chronic Renal Failure Patients at Different Stages, and Evaluation of the Role of Antiphospholipid Antibodies

Start date: October 17, 2023
Phase: N/A
Study type: Interventional

The vascular endothelium is an organ in its own right, playing, among other things, a primordial role in the control of vascular tone. This vascular tone is ensured by pro-dilator mediators (nitric oxide (NO), prostacyclins (PGI2)), or vasoconstrictors (endothelin, thromboxane A2 or PGH2).Uremic toxin accumulation in chronic kidney disease (CKD) is a well-known factor in endothelial dysfunction, often associated with higher cardiovascular risk. This association is also present for terminal chronic kidney disease characterized by the need to resort to an extra-renal purification technique (in-center hemodialysis (HD), daily home hemodialysis (HDQ), peritoneal dialysis) or to resort to renal transplantation. For HD to be effective, it is essential that the blood flow rate passing through the dialyzer is greater than 300ml/min. This imperative requires that any hemodialysis patient have specific vascular access (dialysis catheter or arteriovenous fistula (AVF)) to ensure these flow rates. The vascular access of choice is the arteriovenous fistula , because it is associated with a lower risk of infection and lower morbidity and mortality. Making an arteriovenous fistula consists of surgically creating an anastomosis between a vein and an artery. Complications of arteriovenous fistula are common. Arteriovenous fistula maturation may be delayed (maturation delay) or even absent. Drainage veins and/or anastomoses can also be the site of stenosis or thrombosis. The pathophysiology of these complications is complex and multifactorial. Among the risk factors for these complications (delay or absence of maturation, stenosis thrombosis), the positivity of antiphospholipid antibodies (aPL) can be cited, as well as endothelial dysfunction. Antiphospholipid syndrome (APS) is an autoimmune disease causing a thrombotic phenotype. This is an acquired thrombophilia. In the general population, the prevalence of antiphospholipid antibodies is around 0.5%; this prevalence is far from rare in hemodialysis, since it represents up to 37% in dialysis patients. In a retrospective study carried out at Brugmann University Hospital in 2023 , on 115 patients with AVF and in whom aPL dosages were available, the prevalence of persistent positivity (2 positive dosages spaced more than 12 weeks apart) was 21%. Interestingly, a third of the cohort presented an antibody profile that did not allow them to be classified according to the classification criteria in force. This group corresponds to patients with a single positive dosage, either not recontrolled or recontrolled negative. This group was called Fluctuating. This fluctuating group was associated with arteriovenous fistula complications in a 2019 study. Endothelial dysfunction is also implicated in the pathophysiology of APS. In clinical practice, the "flow mediated dilation" (FMD) test makes it possible to assess endothelial dysfunction in vivo. It involves the phenomenon of post-occlusive hyperemia which is mainly linked to NO and endothelium-dependent vasodilation. In the brachial artery, NO is the sole mediator of FMD. Endothelial dysfunction according to FMD has been described in populations with advanced chronic kidney disease, as well as patients with cardiovascular diseases. Hemodialysis patients with delayed/absence of arteriovenous fistula maturation have more pathological FMDs compared to dialysis patients without fistula problems. However, the additive role of aPL in this different population has not been studied in terms of endothelial dysfunction by FMD. The objective of this study is to evaluate the weight of antiphospholipid biology on endothelial dysfunction in hemodialysis patients, using the FMD test. 1. Compare endothelial dysfunction by FMD according to the stage of chronic kidney disease and in comparison to a control group without chronic kidney disease. 2. Characterize the FMD pre or post dialysis and according to the duration of the long (for example between Thursday and Sunday) vs. short (between Tuesday and Thursday) inter-dialytic period. 3. Evaluate the relationship between endothelial dysfunction according to FMD, aPL positivity and arteriovenous fistula complications in hemodialysis patients. 4. Evaluate the risk factors associated with endothelial dysfunction according to FMD, and in particular evaluate the impact of antiphospholipid antibodies. 5. Evaluate the correlation between endothelial dysfunction according to FMD and other markers of endothelial dysfunction (urinary NO and metabolites of urinary NO, PGI2, endothelin, PGH2).

NCT ID: NCT06337942 Recruiting - Bladder Cancer Clinical Trials

Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant. The main questions it aims to answer are: - Is human bladder transplantation feasible and safe? - How will the new bladder function in terms of storage and emptying? Participants will undergo a bladder-only or combined kidney and bladder transplantation. They will then be followed for two years to evaluate the efficacy, safety, and functionality of the bladder transplant.

NCT ID: NCT06314503 Recruiting - Clinical trials for Chronic Kidney Diseases

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

CORDIAL
Start date: January 22, 2024
Phase: N/A
Study type: Interventional

The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid. The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment. The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions. Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber. Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane).

NCT ID: NCT06298227 Recruiting - Kidney Diseases Clinical Trials

Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries. US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs. This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.

NCT ID: NCT06288451 Recruiting - Clinical trials for Kidney Failure, Chronic

DePTH: De-emphasize PTH

Start date: March 11, 2024
Phase: Phase 2
Study type: Interventional

The De-emphasize Parathyroid Hormone (DePTH) Study is a 12-month pragmatic, randomized, parallel-group, active comparator, open-label, blinded end-point study of 90 patients with incident or prevalent secondary hyperparathyroidism and kidney failure treated with in-center hemodialysis. It tests the hypothesis that low fixed-dose oral calcitriol (intervention) will have more favorable effects on a comprehensive panel of biomarkers that assesses mineral metabolism, bone turnover, and serum calcification propensity, compared with variably-dosed intravenous activated vitamin D titrated to PTH targets (usual care).

NCT ID: NCT06248567 Recruiting - Kidney Impairment Clinical Trials

Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease

Start date: January 15, 2024
Phase: Phase 1
Study type: Interventional

This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of ZSP1273.

NCT ID: NCT06238310 Recruiting - Acute Kidney Injury Clinical Trials

Comparison of Two Different External Clearance Markers - Mannitol and Iohexol for Measuring Glomerular Filtration Rate

GFR
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

GFR is the best parameter of the real kidney function. Measurements, however are time-consuming and have limited capacity. Patients treated in the intensive care units often have more than one organ-insufficiency and acute kidney injury (AKI) has an incidence of up to 70 %. GFR changes dynamically and this is one of the reasons why GFR-measurements have limited indications on the ICU. Retention of medicines or their active metabolites, however can lead to side effects, toxicity and or prolonged ICU-stay. Moreover, patients with allergy to actually standard marker, contrast material iohexol, or gravid patients are not candidate for measuring GFR with iohexol. In this prospective clinical trial two exogen marker substances will be compared, mannitol as a new marker and iohexol as a standard marker for measuring glomerular filtration rate (GFR). Patients in the intensive care units (ICU) and an outpatient group with stable chronic kidney disease (CKD) are included. The main question is, how reliable mannitol-GFR is compared to iohexol-GFR in a wide range of kidney insufficiency. GFR measurements are performed with a bolus injection technique. Patients get mannitol and iohexol bolus at time zero and blood samples are taken three times according to local protocols for iohexol clearance measurements.

NCT ID: NCT06205758 Recruiting - Heart Failure Clinical Trials

Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency

Start date: November 16, 2023
Phase:
Study type: Observational

1. To evaluate the efficacy and safety of levosimendan and milrinone in the treatment of with acute heart failure with or without renal dysfunction; 2. Predictive modeling of the efficacy and safety of levosimendan and milrinone.