XIENCE 28 Global Study
Bleeding DisorderStroke8 moreXIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS, XIENCE PROX EECSS, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With...
Renal ImpairmentThis study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.
Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type...
Renal Impairment in Hepatorenal SyndromeThis study aimed to investigate the efficacy of midodrine plus octreotide versus norepinephrine and to determine the predictive factors of response in patients with HRS-AKI.
Effects of Fasting Mimetic Diet on Nephropatic Patients
Renal InsufficiencyChronicFasting mimetic diet (FMD) showed positive effects on cardiovascular risks. Purpose of the trial is to evaluate FMD effects on patients affected by chronic kidney disease (CKD), through the stimulation of kidney stem cells and improving cardiovascular and metabolic status. From April 2018, the investigators enrolled 13 patients (7 male) with an history of primary glomerulonephritis (GMN) and an eGFR between 60 ml/min and 30 ml/min. Exclusion criteria are: age <18 y.o., age> 65 y.o., secondary GMN, severe heart failure (NYHA IV),ongoing infectious diseases, ongoing neoplasia, hepatic diseases, COPD, inflammatory bowel disease, history of stroke, history of acute coronary disease less than 3 months, pregnancy, refuse informed consent.
Long-term Follow-up of Patients With Chronic Kidney Disease Who Had Administered Cellgram-CKD in...
Renal InsufficiencyChronicThis long-term follow-up study is a 5-year long-term follow-up study to evaluate long-term safety in Cellgram-CKD subjects. (refer to ClinicalTrials.gov.Identifier: NCT05042206).
A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant...
Healthy VolunteersRenal ImpairmentThe purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying levels of renal impairment (mild, moderate and severe) compared to healthy female participants with normal renal function. This study will also evaluate the safety and tolerability of a single oral dose of fezolinetant in female participants with varying levels of renal impairment (mild, moderate and severe) and healthy female participants with normal renal function. Renal function will be measured by estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula: Mild (eGFR 60 to < 90 mL/min per 1.73 m^2) renal impairment; moderate (eGFR 30 to < 60 mL/min per 1.73 m^2) renal impairment, severe (eGFR < 30 mL/min per 1.73 m^2) renal impairment and not on hemodialysis and normal (eGFR ≥ 90 mL/min per 1.73 m^2) renal function.
A Study to Learn How the Study Treatment BAY3283142 Taken as Single Dose by Mouth Moves Into, Through,...
Chronic Kidney DiseaseRenal Impairment1 moreResearchers are looking for a better way to treat people who have chronic kidney disease (CKD). The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. High blood pressure makes it more likely that the CKD gets worse. The study treatment BAY3283142 is under development for treating CKD. It activates a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD. The participants do not benefit from this study. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD. In previous studies, BAY3283142 was studied in participants with normal kidney function. As kidneys play a role in removal of drugs from the body, the degree of kidney function could influence the amount of BAY3283142 in the blood. Higher amounts may occur in people with reduced kidney function. Therefore, the main purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body in participants with mild to severe reduction of kidney function compared to matched participants with normal kidney function. To answer this, the researchers will compare: the (average) total level of BAY3283142 in the blood (also called AUC). the (average) highest level of BAY3283142 in the blood (also called cmax) between the different groups. Participants will be in one of four groups based on how much their kidney function is reduced (mild, moderate, severe, end stage kidney disease) or in the control group. All participants will take a single dose of BAY3283142 as tablet by mouth. Each participant will be in the study for approximately 4 weeks including an in-house stay of 6 days (with 5 overnight stays). In addition, a screening visit to the study site before the in-house stay is planned. During the study, the study team will: check vital signs do physical examinations take blood and urine samples examine heart health using an electrocardiogram (ECG) ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
A Study of the Effect of a Nurse Navigator Program on High Risk Patients
Patient ReadmissionArthroplasty11 moreThe purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic...
Renal InsufficiencyChronic1 moreTo evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir
Hepatitis CChronic1 moreSofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.