35 Clinical Trials for Various Conditions
This study is a pilot study designed to compare the safety and cardiovascular effects of 26 weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in patients receiving chronic hemodialysis. The investigators hypothesize that treatment of chronic hemodialysis (ESRD) patients with a combination of hydralazine/isosorbide dinitrate compared with placebo is safe and that it will improve heart function as well blood flow/blood vessel supply.
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.
The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.
Patients undergoing chronic hemodialysis are at increased risk for cardiovascular disease, attributed in part to increased oxidative stress, inflammation and dyslipidemia. Intervention with a naturally occurring dietary supplement may improve certain biomarkers of inflammation and oxidative stress and improve the lipid profile.
An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population.
Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses. It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.
The trial is an uncontrolled, open-label, parallel group clinical trial. Approximately 10 subjects per dose group in 3 groups will be treated twice weekly for a total of 9 doses, followed by a 4-week observation period. Eligible subjects who have Hgb ≥10.5 g/dL and have stable Hgb levels will start the washout period of one to eight weeks. During the washout period, 30 subjects whose Hgb are \< 10.0 will complete the baseline assessment to confirm their eligibility. Eligible subjects will be randomly assigned to one of the 3 cohorts in a 1:1:1 ratio. Subjects will be admitted on the day of the first dose and stay in the clinic overnight for pharmacokinetic (PK) sampling after the first (day 1) and the last dose (day 29). FMX-8 will be administered as 30 min i.v. infusion. After the 29-day treatment period, the trial subjects will be observed for an additional 28 days to allow safety and immunogenicity assessments.
The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of life and incidence of bacteremia, vascular interventions, hospitalizations, and death.
The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study is to determine whether hemodialysis patients who take CR845 develop physical dependence and experience withdrawal symptoms upon cessation, as exemplified by symptoms consistent with opioid withdrawal. The study will consist of a Screening Phase, a 3-week Open-label Phase, a 2-week randomized, placebo-controlled, Double-blind Phase and a Follow-up Visit.
In this pragmatic clinical trial, which will dovetail with Veterans' routine outpatient dialysis clinic visits in six VA medical centers, the investigators will study 252 Veterans with kidney disease who need to start dialysis treatment. If a Veteran is eligible for the study by making enough residual urine, he/she will have a 50% chance to be offered the usual three-times-per-week dialysis vs. twice-per-week dialysis that is gradually increased to three-times per- week over one year. The investigators will compare health-related quality of life, how long residual kidney function lasts, and other measures including safety in these two groups. By conducting this study, the investigators hope to understand 1) whether starting dialysis with less frequency is safe, effective, and can help Veterans and their care-partners to better cope with dialysis, and 2) if incremental dialysis can result in major cost benefits to the VA health care system, thus allowing more patients to stay in VA dialysis clinics vs. being transferred to outside clinics.
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in advanced chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study is comprised of an Efficacy Assessment Phase and a Long-term Extension Phase. The Efficacy Assessment Phase includes a double-blind 12-week Treatment Period (Treatment Period 1), and the Long-term Extension Phase includes a double-blind Treatment Period (Treatment Period 2) of up to 52 weeks.
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in advanced chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study is comprised of an Efficacy Assessment Phase and a Long-term Extension Phase. The Efficacy Assessment Phase includes a double-blind 12-week Treatment Period (Treatment Period 1), and the Long-term Extension Phase includes a double-blind Treatment Period (Treatment Period 2) of up to 52 weeks.
The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week Double-blind Phase and a 52-week Open-label Extension Phase.
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
Chronic Kidney Disease Stage 5 (CKD5) patients receiving maintenance hemodialysis are at an increased risk for developing bloodstream infections. Vancomycin is traditionally used as first-line therapy for treating these infections, but the emergence of less-susceptible bacterial strains necessitates the consideration of alternative antibiotic therapy. Telavancin is a new antibiotic that has broad-spectrum antimicrobial activity against gram-positive bacteria, including vancomycin-intermediate staphylococcus aureus. While dosing recommendations for telavancin are available for patients with normal kidney function, there are no published recommendations for CKD5 patients receiving hemodialysis. A pharmacokinetic study is needed to characterize the pharmacokinetic parameters of telavancin in these patients to determine the extent of drug removal by hemodialysis and to establish dosing recommendations for CKD5 patients on maintenance hemodialysis.
The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.
The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing fluid overload/weight gain between dialysis sessions for patients with End Stage Renal Disease on Hemodialysis.
The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study.
In the United States, African Americans are 3.6 time and Hispanics 1.5 times more likely to suffer from chronic kidney disease and need dialysis treatment for life, when compared to the non-Hispanic Whites. Unfortunately many dialysis patients die, so that after 5 years only less than 35% are still alive. Dialysis patients who appear malnourished or who have muscle and fat wasting are even more likely to die. Interestingly, among dialysis patients, minorities (African Americans, Hispanics and Asian Americans) usually survive longer than the non-Hispanic Whites. If the investigators can discover the reasons for these so-called "racial survival disparities" of dialysis patients, the investigators may be able to improve survival for all dialysis patients and maybe even for many other people who suffer from other chronic diseases. During this 5 year study the investigators would like to test if a different nutrition and diet can explain better survival of minority dialysis patients. The investigators will also test if in additional to nutrition there are 2 other reasons for better survival of minority dialysis patients, namely differences in bone and minerals and differences in social and psychological and mental health. The investigators plan to study 450 hemodialysis patients every 6 months in several dialysis clinics in Los Angeles South Bay area. These subjects will include 30% African Americans, 30% Hispanics, 30% non-Hispanic Whites and 10% Asians. Every 6 months the investigators will examine their nutritional conditions, dietary intake, psycho-social conditions and quality of life, and will recruit 75 new subjects to replace those who left our study as a result of kidney transplantation, death or other reasons. Hence, the investigators estimate studying a total of 1,050 hemodialysis patients over 5 years. Clinical events such as hospital admissions and survival will be followed. Blood samples will be obtained every 6 months for measurements of hormones and "biomarkers", and the remainder of the blood will be stored in freezers for future measurements. The investigators plan to design and develop race and ethnicity specific nutritional risk scores and food questionnaires and will test some of these scores in larger national databases of hemodialysis patients. Almost a year after the study starts, the investigators also plan to do additional tests of body composition and dietary intake in a smaller group of these patients at the GCRC.
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.
The purpose of this study is to determine whether or not nocturnal hemodialysis is equivalent to short daily hemodialysis on a per treatment basis, using the NxStage System One in the home setting.
The primary goals of this investigation are to provide guidance on how to dose Argatroban in patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in hemodialysis patients. The secondary goal of the study will be to assess the adequacy of anticoagulation during hemodialysis.
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.