16 Clinical Trials for Various Conditions
This phase 2 study is to assess the safety and efficacy of APX-115 active doses in Contrast Induced Acute Kidney Disease compared to placebo following multiple oral dosing in patients with undergoing percutaneous coronary intervention. It is anticipated that approximately 280 patients will be randomized into the study in a 1:1 ratio to 400 mg APX-115 (Isuzinaxib hydrochloride) or placebo arm.
The use of imaging is increasing in clinical practice, either for diagnosis or intervention. In these imaging processes, contrast medium (CM) is widely used. However, CM administration can induce contrast-induced nephropathy (CI-AKI). CI-AKI is the third most common cause of renal insufficiency, and its incidence varies from 2% to 50% depending on patient risk factors; in addition, studies have shown that CI-AKI occurs in 2% to 25% of patients undergoing coronary intervention. CI-AKI is associated with significant mortality and morbidity in patients undergoing coronary angiography or other diagnostic contrast studies. We assessed the latest promising evidence on the ability of remote ischemic preconditioning (RIPC) to reduce the incidence of CI-AKI in patients undergoing Coronary Angiogram (CA) or diagnostic contrast studies such as CT angiogram, while at the same time being a non-invasive, low cost, easy, and safe method with absence of adverse effects. However, more randomized controlled trials are needed to confirm these preliminary results. The aim of this study is to minimize the incidence of CI-AKI at the University of Texas Medical Branch (UTMB). If found to be an effective method, RIPC would help minimize the incidence of CI-AKI in all institutions across the globe, who would adopt this intervention. The primary objective: i) reduce the rise in creatinine to \< 0.5 mg/dL post-CA in moderate to high risk patients and ii) reduce the incidence of renal replacement therapy post-CA in moderate to high risk patients; iii) we also aim to establish that RIPC is safe and effective. We hypothesize that the use of RIPC, when added to standard medical therapy (pre-and post-CA hydration), will mitigate the effects of contrast on the renal vasculature and lessen the incidence of CI-AKI in moderate to high risk patients at the University of Texas Medical Branch. The use of iodinated contrast to visually enhance target vasculature is a widely used diagnostic technique that is performed daily at UTMB, and around the world, for the diagnosis and management of a variety of conditions. A common complication of this procedure is acute kidney injury (AKI), generally referred to as contrast-induced nephropathy (CI-AKI). This complication can range from an isolated rise in serum creatinine to severe renal dysfunction necessitating renal replacement therapy. The incidence of CI-AKI has been reported as approximately 2-50%, depending upon the definition and sensitivity of assay employed to assess GFR in the hospital setting. In addition, CI-AKI is associated with significant mortality and morbidity. If proven to be beneficial, RIPC will bring about a reduction in incidence of CI-AKI, and thus help to reduce hospitalization and mortality from renal etiology following a given contrast procedure.
This a prospective, double-blind, sham-controlled, randomized clinical trial to study the effects of remote ischemic preconditioning on acute kidney injury, vascular and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable angina undergoing coronary angiography and/or percutaneous coronary intervention.
Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and post-operative AKI. The development of CI-AKI after cardiac catheterization is associated with a significant increase in both short-term and long-term mortality and morbidities, as well as an increase in length of stay and cost. The only marker of renal function that has predictive ability is creatinine and it has significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic test for predicting CI-AKI risk would have widespread clinical utility. The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac catheterization.
The primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI.
Contrast induced nephropathy (CN) is a common cause of acute kidney injury and is associated with increased morbidity and mortality and healthcare cost. Iodinated contrast media (ICM) induce kidney injury through vasoconstriction and ischemia as well as direct tubular toxicity. Older subjects, individuals with preexisting kidney disease, diabetes, hypotension, and those exposed to higher volumes of ICM are at higher risks for CN. Within the last several years, multiple strategies have been used in clinical studies to reduce the risk of CN in high risk individuals with inconsistent results. In general, it is agreed that volume expansion is effective in reducing the risk. However, no study has looked at changes in renal blood flow (RBF) in response to volume expansion or after exposure to ICM to investigate its relationship with occurrence of CN. In this proposal, up to 125 individuals with preexisting kidney disease as evidenced by an estimated glomerular filtration rate (eGFR) between 30 - 60 ml/min/1.73 m2 and up to 25 individuals with normal renal function (total of up to 150 individuals) who are scheduled for coronary angiography will be studied. Each individual will have serial measurements of RBF; at baseline, after volume expansion with normal saline, and after exposure to ICM, using the novel technique of contrast enhanced ultrasound (CEU). The investigators will investigate the utility of monitoring RBF with CEU in predicting the occurrence of CN (a rise of \> 0.3 mg/dL or 25% in baseline serum creatinine 48 hours after exposure to ICM) after adjusting for other known risk factors in the group of subjects with reduced GFR. The investigators will also examine the correlation between RBF changes and other urinary and serum biomarkers of kidney injury in this group. Up to 25 individuals with a normal kidney function will be studied in a separate part of the study in which the accuracy of CEU based measurements of RBF will be compared to the RBF and blood flow velocity obtained simultaneously using a Doppler flow probe placed directly inside the main renal artery during coronary angiogram procedure. Total to enroll = 150.
This is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.
This study evaluates the safety of iodinated contrast medium administered to liver transplant candidates with decreased renal function undergoing coronary CT angiography. Incidence of post-contrast acute kidney injury in liver transplant candidates with decreased renal function and normal renal function will be compared.
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.
Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.
Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous coronary intervention (PCI) is one of the common procedures which require the use of intravenous contrast media. The reported incidence of contrast induced nephropathy (CIN) in high-risk patients following CAG varies from 10% to 30%. The high rate of CIN in post-PCI patients could be related either to the patient (advanced age, previous CKD, diabetes, dehydration, and concomitant use of other nephrotoxic drugs) or procedure related (intra-arterial route of administration, use of high osmolar contrast media, repeated exposure to contrast within 48 hours, volume of contrast used). Several strategies to prevent or treat CIN have been developed, including hydration, N-acetyl-cysteine, statins, ascorbic acid, bicarbonate, aminophylline, forced diuresis, renal replacement therapy, and choice of low-osmolarity or alternative agents, but one of the most obvious means is to minimize contrast volume. The DyeVert plus Contrast Reduction System, is designed to lower the amount of contrast dye the kidneys are exposed to during a procedure. Because the amount of contrast dye is precisely controlled. The purpose of this prospective study is to understand how the monitoring system of Dye-Vert Plus will impact Acute Kidney Injuries rates in high-risk patients undergoing cardiac catheterization when used in conjunction with a standardized hydration policy.
Both, CT scans and VQ scans, are used by doctors to look for pulmonary embolism. The most common reason to order a VQ scan is to avoid the IV dye. The IV dye used for CT scans can cause kidney problems in some patients, called contrast-induced nephropathy or "CIN." This is a kidney problem that usually does not make patients feel any differently or change how they urinate. Most of the time, it can only be found by testing blood several days later. This kind of kidney problem can be very mild and some patients will never have any symptoms, rarely these problems can be severe. Some patients can also have similar kidney problems for many other reasons (reactions to medications, blood pressure problems, etc.) and can even happen in patients that do not get IV dye. That is why doctors are not sure exactly who will have these problems or if using a test that does not use IV dye can prevent this kidney problem. The VQ scan uses a different medication through the IV that is not IV dye and has not been linked to kidney problems. The purpose of this study is to learn if using the test that does not use IV dye (the "VQ scan") instead of a CT scan in some patients can help to prevent kidney problems.
This study will involve measurement of levels of a novel urinary biomarker of renal ischemia, L-FABP. The purpose of the study is to perform a clinical validation of the ability of L-FABP measurements in urine using the RENISCHEM L-FABP POC Test to predict the development of AKI within 2 days following cardiac and vascular catheterization procedures involving exposure to radiocontrast media.
This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease. Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.
This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is to demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various incremental doses, and to demonstrate the safety and tolerability of the rate of the emulsion vehicle infusion in healthy volunteers. In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.
This is a prospective, observational, multi-center study with consecutive enrollment. Up to 500 patients will be enrolled. All (consecutive) adult patients in whom one or more components of the Benephit Infusion System are planned to be used at participating sites are eligible for enrollment. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, AngioDynamics will be able to (1) Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents, (2) Collect user-interface information and overall customer satisfaction, and (3) Monitor post-marketing device performance and safety for ISO quality adherence.