62 Clinical Trials for Various Conditions
The goal of the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time. Researchers will compare what happens to MK-5684 after hemodialysis in people with severe renal impairment and end-stage renal disease versus healthy people.
The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278. This study plans to use a staged design based on RI severity.
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of resmetirom and its major metabolite (MGL-3623) following oral administration of 100 mg resmetirom (QD x 6 days) in subjects with severe renal impairment (RI) compared to healthy matched control subjects with normal renal function.
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.
The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.
The primary purpose is to assess the effect of renal impairment on the PK of tavapadon following administration of a single oral dose in participants with severe renal impairment relative to age, body weight, and sex-matched participants with normal renal function.
This purpose of this study is to evaluate the plasma pharmacokinetics (PK) of N-hydroxycytidine (NHC), the nucleoside metabolite of molnupiravir, after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. This study will also assess the safety and tolerability of molnupiravir in participants with severe renal impairment and the urinary excretion of NHC after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. The primary hypothesis is that the plasma PK participants with severe renal impairment will be similar to that observed in the healthy mean matched control participants.
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease. In addition it is important to understand how well tolerated Amisulpride is in this patient population. Healthy adults will be studied to provide a comparison.
The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of gilteritinib in male and female participants with severe renal impairment compared to healthy male and female participants with normal renal function. This study also evaluated safety and tolerability of a single oral dose of gilteritinib in male and female participants with severe renal impairment and healthy male and female participants with normal renal function. Part 2 of the study (mild and moderate renal impairment) was not conducted based on the final pharmacokinetic findings from part 1 (severe renal impairment).
This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK, safety and tolerability of Aztreonam-Avibactam. Results from this study along with previous renal impairment data from each of the Aztreonam-Avibactam components will be used to confirm the proposed dosing adjustment in severe renal impairment which was based on modelling/simulation.
This will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.
This study will evaluate the general tolerability and pharmacokinetics (PK) of a single 60 mg dose of MK-8591 (Islatravir) in participants with severe renal insufficiency, compared to participants in good health.
This study is intended to be a single-site, prospective, randomized, double-blinded study that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of rocuronium). A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. All patients will be monitored with continuous pulse oximetry postoperatively for 24 hours.
The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment. Participants will be on study for up to 6 weeks; this includes a 2-week screening and a follow-up about 10 days after final drug administration.
This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.
Despite emergence of new anticoagulants over the last few years, patients with advanced chronic kidney disease still have limited options and are usually managed with warfarin after venous thromboembolism or diagnosis of atrial fibrillation. The use of all direct oral anticoagulants is not recommended in patients with creatinine clearance below 15 mL/min. Apixaban has the lowest fraction of renal excretion (27%) and is sometimes used in patients with CKD V (GFR \< 15 mL/min/BSA) and end stage renal disease (ESRD). Until recently, data on apixaban use in this population were limited to pharmacodynamics as patients with severe renal impairment were excluded from clinical trials. In a 2016 study, it was found that ESRD resulted in 36% increase in apixaban AUC but no increase in Cmax, and that hemodialysis had a limited impact on apixaban clearance.1 There are now data available on inpatient use of apixaban vs.coumadin in patients with creatinine clearance below 25 ml/min.2 There was no significant difference in bleeding events between the two groups but the study period was limited to a hospital admission and may not reflect bleeding risk of long-term anticoagulation. Use of warfarin in patients on hemodialysis entails several disadvantages in this population. The need for INR monitoring adds clinic visits for patients that already spend a great portion of their time in healthcare facilities. Numerous drug interactions, involving warfarin, complicate management of ESRD patients that are often on many medications. The reduced risk of intracranial bleeding on apixaban, compared to warfarin, in the ARISTOTLE study, is an important consideration in patients that may already be at increased risk due other factors such as uremia and concurrent antiplatelet agents.
Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.
Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function.
The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function.
The primary objective of this study is to evaluate the potential effect of renal impairment on the systemic pharmacokinetics of acute Intranasal RX0041-002. The secondary objective is to evaluate the safety and tolerability of acute Intranasal RX0041-002 in subjects with normal renal function and severe renal impairment.
A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based on their level of renal function (normal, mild, moderate, or severe renal impairment) and receive belinostat dose A for normal or mild renal impairment, and dose B for moderate or severe renal impairment.
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal renal function or severe (eGFR \<30 mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the pharmacokinetics (PK) of TD 4208.
The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.
GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development for both the treatment and prevention of human immunodeficiency virus (HIV) infection. Renal elimination of unchanged 744 is extremely low, with no parent 744 detected in the urine after a single 30 mg radiolabeled dose. Despite the minimal contribution of renal clearance on overall 744 elimination, renal impairment may potentially inhibit some pathways of hepatic and gut drug metabolism and transport, and as a result may impact 744 pharmacokinetics. The current Food and Drug Administration (FDA) draft guidance for renal impairment studies suggests that a pharmacokinetic (PK) study in patients with renal impairment be conducted even for those drugs primarily metabolized or secreted in bile. The study will be comprised of two cohorts (severe renal impairment and normal renal function) of 8 subjects each. Upon enrolment, each subject will be admitted to the study center and undergo serial PK sampling following a single dose of oral 744 30 milligrams (mg). Subjects will return to the clinic for follow-up evaluations 10-14 days after the 744 30 mg dose.
The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis.
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
The purpose of this multicenter, open-label, non-randomized, single, oral dose, sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg) administered to healthy subjects and to subjects with renal impairment.
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with severe renal impairment and matched healthy volunteers with normal renal function.
The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.