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Active clinical trials for "Renal Insufficiency"

Results 1241-1250 of 1903

Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function...

Renal ImpairmentHealthy Participants

The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired renal function compared to matched control subjects with normal renal function

Completed25 enrollment criteria

A Study to Learn How the Study Treatment BAY1753011 Moves Into, Through and Out of the Body, How...

Congestive Heart FailureRenal Impairment

Researchers are looking for a better way to treat people with heart failure. Heart failure is a condition which occurs when the heart does not pump blood as well as it should leading to shortness of breath, tiredness, and ankle swelling. The study treatment BAY1753011 is under development to treat heart failure. It is thought to reduce the action of a hormone called vasopressin that is naturally produced in the body. People with heart failure often have elevated levels of vasopressin. This is known to result in worsening of the heart failure condition. People with heart failure often also have reduced kidney functions. As kidneys play a role in removal of drugs from the body, reduced kidney function may result in higher blood levels of BAY1753011. The main purpose of this study was to learn how BAY1753011 moved into, through and out of the body in participants with different degrees of reduced kidney function compared to matched participants (age, gender, and weight) with normal kidney function. To answer this, the researchers compared: the (average) total level of BAY1753011 in the blood (also called AUC) the (average) highest level of BAY1753011 in the blood (also called Cmax) between the different groups with reduced kidney function (mild/moderate/severe) and the control group (normal kidney function). In addition, the researchers wanted to know how safe BAY1753011 was and the degree to which overt medical problems caused by it could be tolerated (also called tolerability) by the different groups of participants. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. All participants took a single dose of BAY1753011 in tablet form by mouth. Each participant was in the study for approximately 3 to 4 weeks, including an in-house phase of 5 days and 4 nights with one treatment day. During the study, the doctors and their study team: did physical examinations checked vital signs such as blood pressure, heart rate, body temperature and number of breaths within a minute (respiratory rate) examined heart health using electrocardiogram (ECG) took blood and urine samples counted the number of toilet visits during the night

Completed23 enrollment criteria

A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a...

Contrast Enhancement in Magnetic Resonance Imaging

Researchers in this study want to learn how a new contrast agent for magnetic resonance imaging (MRI) called BAY1747846 moves into, through and out of the body (pharmacokinetics) after injection in participants with normal and impaired renal function. Impaired renal function is a condition where the kidneys do not work as well as they should. BAY1747846 belongs to the class gadolinium-based contrast agents (GBCAs). The way the body removes GBCAs including BAY1747846 from the blood is through the kidneys. So, when the kidneys are not working normally, it takes longer to remove BAY1747846 out of the body. The participants in this study will either have normal renal function, or will have mild or moderate impaired renal function. The participants will receive BAY1747846 one time through a needle into a vein. During the study, the participants will visit the study site about 6 times. The participants will stay at the study site for up to 9 days. Each participant will be in the study for up to 7 months. During the study, the doctors will: check the participants' overall health take blood and urine samples ask the participants about what medications they are taking 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.

Completed27 enrollment criteria

A Study of Epetraborole Tablets in Subjects With Degrees of Renal Function

Renal Insufficiency

This is a Phase 1 study to evaluate the pharmacokinetics (PK), safety and tolerability of epetraborole tablets in adult subjects with normal renal function, subjects with various degrees of renal impairment, and subjects with end-stage renal disease (ESRD) receiving intermittent hemodialysis (IHD) therapy.

Completed39 enrollment criteria

Renal Impairment Study of PF-06700841

Healthy VolunteerRenal Impairment

The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.

Completed9 enrollment criteria

Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients

Transplant;Failure,Kidney

Detecting allograft injury and rejection is critical to preventing graft loss. The current standard of care (SoC) relies on serum creatinine (SC) and biopsy to monitor for and identify kidney injury earlier. SC has poor specificity and sensitivity and response to rejection is often delayed. Protocol biopsy is more accurate but involves the risk of complications. A more definitive, less invasive method for monitoring injury and early rejection is needed. We report on the clinical utility of donor-derived cell-free DNA (dd-cfDNA) in transplant recipients' blood, measured using a novel SNP-based mmPCR NGS methodology, to diagnose allograft injury/rejection. In this study, investigators will measure how use of dd-cfDNA changes clinical practice.

Completed11 enrollment criteria

Glasdegib Renal Impairment Study

Renal Impairment

The goal of this study is to administer single dose (100 mg) glasdegib tablet to subjects with normal, moderate and severe renal impairment and estimate the effect, if any, of this renal impairment on glasdegib pharmacokinetics.

Completed31 enrollment criteria

Pharmacokinetics Study of Asciminib in Subjects With Impaired Renal Function Compared to Matched...

Renal Impairment

The purpose of this study is to characterize the pharmacokinetics (PK) and safety profile of asciminib following a single oral dose in adult subjects with renal impairment compared to a matched group of healthy subjects with normal renal function. The results will determine whether or not a dose adjustment should be recommended when treating patients with asciminib who have impaired renal function.

Completed18 enrollment criteria

Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical...

CardiomyopathyRenal Impairment

To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral response to acute sodium loading in subjects with preclinical systolic dysfunction (PSD) and renal (kidney) dysfunction.

Completed39 enrollment criteria

Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical...

CardiomyopathyRenal Impairment

To determine the effect of 12 weeks of chronic PDEV inhibition with Tadalafil versus placebo on basal cardiorenal and humoral function and on the integrated cardiorenal and humoral response to acute sodium loading in subjects with preclinical Diastolic dysfunction (PDD) and renal (kidney) dysfunction

Completed40 enrollment criteria
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