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Renal Insufficiency clinical trials

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NCT ID: NCT06431789 Recruiting - Renal Insufficiency Clinical Trials

Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency

Start date: May 1, 2024
Phase:
Study type: Observational

1. To provide reference for clinical rational use of edoxaban; 2. Optimize the individualized dosing regimen of edoxaban.

NCT ID: NCT06408597 Recruiting - Prostate Cancer Clinical Trials

Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy

Start date: May 12, 2024
Phase: N/A
Study type: Interventional

Laparoscopic and minimally-invasive robotic access has transformed the delivery of urological surgery. While associated with numerous desirable outcomes including shorter post-operative stay and faster return to preoperative function, these techniques have also been associated with morbidity such as reduced renal blood flow and post-operative renal dysfunction. The mechanisms leading to these renal effects complex are multifactorial, and have not been fully elucidated. However they are likely to include direct effects from raised intra-abdominal pressure, and indirect effects secondary to carbon dioxide absorption, neuroendocrine factors and tissue damage from oxidative stress. It is well documented that pneumoperitoneum places profound stress on the cardiovascular, respiratory and gastrointestinal systems; it also places strain on the renal system. During robotic surgery, continuous pneumoperitoneum and continuous rising of intra-abdominal pressure causes transient oliguria. Moreover, kidney function, estimated by the GFR, deteriorates during elevated intra abdominal pressure (IAP), and most of the studies identified decrease in renal blood flow (RBF) and renal cortical perfusion. Studies conducted to assess the contribution of the nitric oxide (NO) system to the renal hemodynamic/function alterations during pneumoperitoneum, concluded that these adverse effects are probably related to interference with the NO system, and could be partially ameliorated by pretreatment with nitroglycerine. Mannitol is an osmotic diuretic and a renal vasodilator that promotes tubular flow, prevents intratubular cast formation, decreases postischemic cellular swelling, and might serve as a free radical scavenger. Mannitol has traditionally been administered before renal surgeries to minimize perioperative renal dysfunction according to preclinical animal studies and clinical experience with renal transplantation. However, high-level clinical data in support of this belief are not available. The aim of this study is to characterize the effects of increased intra-abdominal pressure on renal perfusion and function in cases undergoing robotic lower tract urologic surgeries, and to assess the contribution of either mannitol or nitroglycerin infusion to the renal hemodynamic/function alterations during pneumoperitoneum.

NCT ID: NCT06407375 Recruiting - Renal Impairment Clinical Trials

Assessment of Renal Function by Multiparametric MRI

Start date: May 1, 2023
Phase: Early Phase 1
Study type: Interventional

Metabolic syndrome is a collection of conditions that affect at least three of the following five criteria: abdominal obesity, high blood pressure, high fasting glucose levels, high triglyceride levels, and low levels of high-density lipoprotein (HDL) cholesterol. Chronic kidney disease (CKD) is a common complication of metabolic syndrome, with an estimated prevalence of 13-40%. Early diagnosis of progressive conditions before the onset of reduced glomerular filtration rate (GFR) or albuminuria may be of clinical benefit but is not possible at present. Furthermore, the diagnosis and quantification of CKD in the context of metabolic syndrome is challenging due to the lack of reliable diagnostic biomarkers, and the current methods may not accurately reflect kidney function in patients with metabolic syndrome. Magnetic resonance imaging (MRI) has been sparsely explored as a potential tool to assess renal perfusion, oxygenation, and fibrosis. Multiparametric MRI (mpMRI) combines several different imaging techniques to provide a more comprehensive evaluation of tissue structure and function. These techniques hold promise for non-invasive assessment of kidney function, but their clinical utility is still largely experimental. Therefore, we aim to conduct an exploratory study to investigate the reliability, reproducibility as well as the validity of parameters for kidney function of multiparametric MRI as well as compare these parameters in between healthy patients and patients with metabolic syndrome.

NCT ID: NCT06407154 Recruiting - Stroke Clinical Trials

Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures: an Observational Study, 2nd Wave

CLIMATE-II
Start date: May 21, 2024
Phase:
Study type: Observational

The CLIMATE-II Observational Study examines to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific health behavior, somatosensory amplification, risk and benefit perception, self-efficacy, health literacy, degree of urbanisation of the patients' administration district and characteristics of the patients' neighborhood are associated with these effects.

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: NCT06362759 Recruiting - Clinical trials for Chronic Kidney Diseases

A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP

TRANQUILITY
Start date: May 15, 2024
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 in participants with chronic kidney disease and elevated hs-CRP.

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: NCT06352411 Recruiting - Healthy Clinical Trials

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

Start date: May 8, 2024
Phase: Phase 1
Study type: Interventional

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems. BI 456906 is being developed to treat people with obesity and liver problems. People living with these conditions often also have kidney problems. Therefore, it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood. Study participants receive a single dose of BI 456906 as an injection under the skin. Participants are divided into 4 groups based on how well their kidneys work: 1 group without kidney problems, and 3 groups with mild, moderate, and severe kidney problems. Each participant without kidney problems is matched with participants from the other groups based on factors such as age, gender, race, and body mass index (BMI) to ensure accurate comparisons. Participants are in the study for about 2 months. They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The participants also answer questions about their well-being. The doctors regularly check participants' health and take note of any unwanted effects.

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: July 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.