The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
Pulmonary Arterial HypertensionRenal DysfunctionThis is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis). Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis. Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with ESRD will have a sample taken at 60 hrs post dose.
Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.
Kidney FailurePatients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.
Donor Simvastatin Treatment in Organ Transplantation
Heart FailureRespiratory Failure3 moreThe aim of the study is to investigate the effects of donor simvastatin treatment on ischemia-reperfusion injury after heart transplantation.
PK Study of ACHN-490 Injection in Renally Impaired Subjects
Renal InsufficiencyThe purposes of this study is to assess the relationship between renal function and pharmacokinetics of ACHN-490 Injection.
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment....
Diabetes MellitusType 2This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
Kidney TransplantationKidney Failure3 moreTo compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Kidney FailureKidney DiseasesMuscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are reduced, and likely contributes to the wasting. As TT in relatively safe physiologic replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we hypothesize that physiologic TT replacement will be effective in preventing and treating the loss of muscle mass and function in CKD patients, will improve quality of life and may reduce some cardiovascular disease (CVD) risk factors.
Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving...
AnemiaChronic Renal Failure1 moreThe purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.
Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency
Urologic DiseasePrevious study showed repeated lead chelation therapy significant reduced progressive renal insufficiency in patients with chronic renal diseases and high-normal body lead burden in a placebo-controlled, randomized, 2-year clinical trial, even factors that influence progression, such as blood pressure, the presence or absence of hyperlipidemia, and urinary protein excretion were well controlled.Since relative small sample size and short duration of follow-up were noted in the previous study, whether repeated lead chelation therapy could long-term retard the progression of renal insufficiency remains unknown. Hence, we conducted a 51-month placebo-controlled clinical trial to assess the long-term effect of repeated chelation in progressive renal insufficiency of patients with high-normal body lead burden.
Peginesatide for Anemia in Chronic Hemodialysis Patients
AnemiaChronic Kidney Disease1 moreThe purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with chronic kidney disease (CKD) who are on hemodialysis.