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Renal Impairment clinical trials

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NCT ID: NCT05992155 Completed - Healthy Volunteers Clinical Trials

A Study of TAK-279 in Adults With or Without Kidney Problems

Start date: September 27, 2023
Phase: Phase 1
Study type: Interventional

The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with kidney problems compared to participants without kidney problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279. The participants will need to stay at the clinic for 11 days.

NCT ID: NCT05916573 Completed - Renal Impairment Clinical Trials

A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment

Start date: December 12, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of HSK16149 in subjects with mild, moderate and severe renal impairment compared to the matched control subjects with normal renal function.

NCT ID: NCT05793450 Completed - Renal Impairment Clinical Trials

Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

Start date: May 5, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess how fast IBI362 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

NCT ID: NCT05711381 Completed - Renal Impairment Clinical Trials

Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function

Start date: December 2, 2022
Phase: Phase 1
Study type: Interventional

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function

NCT ID: NCT05673603 Completed - Renal Impairment Clinical Trials

A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment

Start date: July 20, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to determine the pharmacokinetics (PK) following a single oral dose administration of brensocatib, safety, and tolerability of brensocatib when administered to participants with impaired renal function and in healthy participants.

NCT ID: NCT05631938 Completed - Renal Impairment Clinical Trials

Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose

Start date: January 10, 2023
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are: 1. To obtain information on the pharmacokinetics of cytisinicline following a single oral dose in subjects with varying degrees of renal impairment relative to matched controls with normal renal function. 2. To investigate the extent of cytisinicline removal by hemodialysis.

NCT ID: NCT05599997 Completed - Clinical trials for Congestive Heart Failure

A Study to Learn How the Study Treatment BAY1753011 Moves Into, Through and Out of the Body, How it Works, How Safe it is, and How it Affects the Body When Given Once as Tablet in Male and Female Participants With Reduced Kidney Function Compared to Matched Participants With Normal Kidney Function

Start date: November 25, 2019
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT05515458 Completed - Renal Impairment Clinical Trials

Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function

Start date: November 20, 2022
Phase: Phase 1
Study type: Interventional

This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with renal impairment compared to subjects with normal renal function.

NCT ID: NCT05515432 Completed - Healthy Volunteers Clinical Trials

A Study to Learn How the Study Treatment BAY3283142 Taken as Single Dose by Mouth Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function of Similar Age, Gender, and Weight

Start date: August 11, 2022
Phase: Phase 1
Study type: Interventional

Researchers 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.

NCT ID: NCT05497297 Completed - Renal Impairment Clinical Trials

A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment

Start date: August 4, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics and safety of HSK7653 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function.