Active clinical trials for "Kidney Diseases"

This study evaluates the effect of a single cognitive-behavioral intervention (CBI) in a control group against the same CBI plus the strengthening of resiliency skills in an experimental group, on ESRD patients.

Ticagrelor is a potent and fast-acting P2Y12-ADP receptor antagonist recommended as first-line agent in ACS (2). This drug was associated with a 20% relative reduction in the rate of MACE in ACS patients undergoing PCI compared to clopidogrel. This benefit came without any increase in major bleedings compared to clopidogrel (6). In the PLATO trial, a limited number of kidney failure patients were included (21%) and patients with terminal CKD were excluded. A sub-group analysis focused on CKD patients was performed. Only 214 patients with CKD below stage 4 (creatinine clearance <30 ml/min) were included (7). No patient with terminal CKD or undergoing chronic hemodialysis was included. Of importance, kidney function impairment is frequent and affects up-to 40 % of ACS patients. In addition, CKD is a powerful independent predictor of ischemic complications during ACS (8-9).Indeed, CKD patients have a very high risk of MACE following ACS with an odd ratio between 2 and 3 compared to patients with normal kidney function and event rates above 40% at one year follow-up (8-13). Of importance these patients more often have high on-clopidogrel platelet reactivity which was strongly associated with a worse clinical outcome (3,14-16). In CKD patients HTPR was associated with death after PCI (15). Accordingly ticagrelor which overcomes these limitations of clopidogrel could be associated with a major clinical benefit in severe or terminal CKD patients. Most of ticagrelor and is active metabolites are excreted through the feces. Preclinical data suggested that renal impairment had little effect on systemic exposure to the drug(EMEA/H/C/1241 (28)). Recent pharmacodynamic and kinetic studies confirmed these preclinical data on the safety of ticagrelor in severe and end-stage CKD (17-19). Therefore based on the rational above and to the lack of relevant clinical data, the optimal P2Y12-ADP receptor antagonist for patients with stage 4 and 5 and patients undergoing chronic dialysis remains undetermined in ACS treated with PCI. We aimed to compare the clinical efficacy ticagrelor and clopidogrel in patients with stage 4 and 5 or on chronic hemodialysis undergoing PCI for ACS.

Wharton Jelly derived Mesenchymal stem cells will be injected in the renal parenchyma of patients with Diabetic Nephropathy

Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults and one of the leading known causes of end-stage renal disease. Identification of circulating autoantigens provide potential biomarkers for diagnosis and therapy of idiopathic membranous nephropathy. M-type phospholipase A2 receptor (PLA2R) and Thrombospondin type-I domain-containing 7A (THSD7A) were identified as the target antigen in membranous nephropathy with high specificity and the concentration of serum anti-PLA2R antibody and anti-TSHD7A antibody were helpful for predicting disease activity. In our prospective cohort study, hospitalized patients diagnosed as IMN are prospectively studied. Circulating anti-PLA2R antibody and anti-THSD7A antibodies were recently screened by using enzyme-linked sorbent assay(ELISA). This study aims to analyse the difference of clinicopathological characteristics for different concentrations of serum anti PLA2R antibody and anti TSHD7A antibody, and analyze the association between baseline concentrations of serum antibody and disease activity. This study also explored the prediction effects of serum antibody concentrations with different types of therapeutic regimen in IMN and compare the curative effects of different types of therapeutic regimen in different serum antibody concentrations.

The pathophysiology of diabetes is multifactorial. Beyond genetic susceptibility loci, a lot of acquired risk factors are involved in the development and progression of the disease. Chronic complications of diabetes can be divided into vascular and nonvascular. The risk of developing complications increases with the duration of hyperglycemia, and usually become apparent in the second decade of hyperglycemia. Vascular complications are further subdivided into microvascular (retinopathy, nephropathy and neuropathy) and macrovascular (coronary artery disease, peripheral arterial disease, cerebrovascular disease). It is estimated that the annual decline of estimated glomerular filtration rate (eGFR) in diabetic adults is about 2.1-2.7 ml/min. While there is consolidated evidence about the use of aspirin (ASA) for secondary prevention in diabetic patients, there is no consensus on the use in primary prevention; the use of ASA in these patients is at physician discretion. ASA is an effective antithrombotic agent that inhibits the production of thromboxane (Tx) A2 and other prostaglandins by blocking cyclooxygenase (COX). In patients treated with aspirin, serum TxB₂ level is the most reliable in vivo indicator of COX-1 inhibition than TxA2, due to its short half-life and artifacts associated with platelet activation ex vivo. COX are present in the kidney in the macula densa, in the medulla and in the interstitium. Experimental animals models have demonstrated that COX are involved in regulation of renal blood flow. In particular, in a murine animal model, after the administration of COX inhibitors such as aspirin and celecoxib, it was observed an improvement in renal plasma flow and eGFR, suggesting a role for Tx in the progression of renal damage However, data on the relationship between aspirin and renal function in humans are scarce. In a recent work lead on a large cohort of 800 patients with non-valvular atrial fibrillation, ASA use was associated with a reduced progression of eGFR <45 ml/min during 2 years of follow-up. Furthermore, basal levels of urinary excretion of TxB2, correlated inversely with the use of aspirin and with the decrease of eGFR at follow-up. The aim of the study is to evaluate the decline in renal function in diabetic patients treated with low-dose aspirin (100 mg/day) vs. untreated diabetic patients.

Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.

This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy.

The purpose of this study is to compare the effect of fosinopril plus benidipine vs. fosinopril plus hydrochlorothiazide on the renal function during the 6-month treatment in CKD patients with HTN.

In a prospective international multicenter observational study, 1080 stable chest pain patients (REALITY Advanced registry of CCTA patients) with the suspected chronic coronary syndrome will be enrolled. All of them will undergo computed tomography angiography, CMR and/ or SPECT, and Echo. One of the cohorts will be examined with multimodality invasive imaging including quantitative coronary angiography, FFR, QFR with or without further percutaneous coronary intervention, OCT, and some of them - with IVUS, VH-IVUS. The plaque size and relevant stenosis, a composition of the atherosclerotic lesion, major adverse cardiovascular events (all-cause death, death from cardiac causes, myocardial infarction, or rehospitalization due to unstable or progressive angina, ischemia-driven revascularization) will be judged to be related to either originally treated (culprit) lesions or untreated (non-culprit) lesions. Moreover, the clinical potential of both non-invasive and invasive imaging, as well as anatomical vs functional modalities in two real-world patient flows, will be estimated with the special focus on the natural progression of atherosclerosis, clinical outcomes, and safety (contrast-induced nephropathy, radiocontrast-induced thyroid dysfunction, and radiation dose). The diagnostic accuracy will be analyzed. The follow-up period will achieve 12 months prospectively with collected clinical events and imaging outcomes which will be determined at the baseline and 12-month follow-up. The independent ethics expertise will be provided by the Ural State Medical University (Yekaterinburg, Russia) and Central Clinical Hospital of the Russian Academy of Sciences (Moscow, Russia). The monitoring of the clinical data with imaging as well as further CoreLab expertise (expert-level post-processing multimodal imaging software of Medis Imaging B.V., Leiden, The Netherlands) will be provided by De Haar Research Task Force, Amsterdam-Rotterdam, the Netherlands. FFR-CT is scheduled to be assessed by the ElucidVivo Research Edition software from Elucid Bio, Boston, MA, U.S.A. The REALITY project is a part of the JHWH (Jahweh) International Advanced Cardiovascular Imaging Consortium. The main objective of the Consortium that is uniting international efforts of both Academia and Industry is a synergistic development of the advanced machine-learning imaging software in order to integrate benefits of both non-invasive and invasive imaging providing the daily clinical practice with the robust tool for the anatomical and functional examination of coronary atherosclerosis, PCI-related arterial remodeling, and relevant myocardial function.

A 4 week-duration cross-over study on Ticagrelor and Clopidogrel for the Acute Coronary Syndrome (ACS) and Chronic Kidney Disease (CKD) subjects, focusing on the platelet inhibition and safety observation.