Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment
InfectionHuman Immunodeficiency Virus1 moreGSK1265744 (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 The current Food and Drug Administration (FDA) draft guidance for renal impairment studies suggests that a pharmacokinetic (PK) study in patients with renal impairment be conducted even for those drugs primarily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.
Effects of a Transitional Palliative Care Model on Patients With End-stage Renal Failure
Palliative CareRenal Failure1 morePrimary aim: To compare the effects of customary care and an interventional Home-based Palliative Renal Program (HBPRP) for ESRF patients To compare the effects of customary care and Home-based Palliative Program (HBPP) for ESRF patients Secondary aim: To explore the lived experiences of patients with ESRF. Hypothesis The transitional renal palliative care model is associated with decreased in unscheduled hospital readmission, reduce length of stay as well as improved quality of life for patients with end-stage renal failure.
PK of Serelaxin in Severe Renal Impairment and ESRD
Renal FailureChronic1 moreThe study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.
Improving Communication About Serious Illness
Critical IllnessChronic Disease12 moreThe purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting. We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families. To do this we created a simple, short feedback form. The form is designed to help clinicians understand what patients would like to talk about. The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families.
Dietary Protein Requirements in Hemodialysis Patients
Chronic Renal FailureEnd-Stage Renal DiseaseThe primary purpose of this study is to assess dietary protein requirements in clinically stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.
Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in...
Renal ImpairmentThis study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.
Pulmonary And Renal Support During Acute Respiratory Distress Syndrome
Acute Respiratory Distress SyndromeAcute Renal FailureIn patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension. Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome. The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased. For this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.
Dexpramipexole Renal PK Study
Amyotrophic Lateral SclerosisRenal InsufficiencyThis is a multicenter, open-label, single-dose, PK and safety study in subjects with various stages of renal impairment.
A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment
Renal ImpairmentThe PK and safety profiles to be examined following a single oral administration of TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to subjects with normal renal function.
Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction...
HyperkalemiaChronic Kidney Disease1 moreIt is hypothesized that zirconium silicate is safe and well tolerated and more effective than placebo (alternative hypothesis) in lowering serum potassium levels in subjects with serum potassium between 5 - 6.0 mmol/l versus no difference between zirconium silicate and placebo (null hypothesis). It is hypothesized that zirconium silicate even up to the top dose of 10g three times a day is well tolerated.