Clinical trials: End-stage Disease
End Stage Liver Disease
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.
- Trial name
- NCT04496479
- Testing
- LYG-LIV0001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- LyGenesis, Inc.
End Stage Renal Disease
Evaluation of STARgraft-3 for Hemodialysis
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft.
- Trial name
- NCT05729620
- Testing
- Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 21 people
- Sponsor
- Healionics Corporation
End Stage Renal Disease
Evaluation of STARgraft-2 for Hemodialysis Access
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft.
- Trial name
- NCT04783779
- Testing
- Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- Healionics Corporation
Renally Impaired Subjects
Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects
This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1…
- Trial name
- NCT02313103
- Testing
- lofexidine HCl
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Kidney Disease, Peritoneal Dialysis (PD)
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.
- Conditions
- Kidney Disease, Peritoneal Dialysis (PD), End Stage Kidney Disease (ESRD)
- Trial name
- SCALE-PD (NCT07059962)
- Testing
- Bodyport Cardiac Scale
- Where
- 7 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Bodyport Inc.
Renal Failure, End Stage Renal Disease
Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration
The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration
- Trial name
- eMPORA II (NCT03611218)
- Testing
- Dialyzer
- Where
- 6 sites in Germany
- Volunteers
- 71 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Chronic Hepatitis C, Hepatitis C Virus
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis, Severe Renal Impairment
- Trial name
- NCT02207088
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, Ribavirin
- Volunteers
- 68 people
- Sponsor
- AbbVie
Renal Insufficiency, Hemodialysis
A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)
A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication
- Trial name
- NCT00418366
- Testing
- MK0431, sitagliptin phosphate / Duration of Treatment : 1 Days
- Volunteers
- 24 people
- Sponsor
- Merck Sharp & Dohme LLC
Mild Cognitive Impairment (MCI), Early Stages of Cognitive Decline
Mild Cognitive Impairment Community Screening and Early Intervention Via Stem Cell Therapy and Wearable Brain Computer Interface Device.
This study aims to evaluate the efficacy of community-based early detection and targeted interventions, including stem cell therapy and wearable non-invasive brain-computer interface (BCI) devices, for Mild Cognitive Impairment…
- Conditions
- Mild Cognitive Impairment (MCI), Early Stages of Cognitive Decline, Alzheimer's Disease Dementia, Alzheimer's Disease Diagnosis
- Trial name
- MCITestCare (NCT07214974)
- Testing
- Structured wellness care, Wearable brain-computer interface devices, Stem Cell Therapy - Experimental
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Noah Tech, Corp.
Age-related Macular Degeneration
Telescope Exchange Study
VisionCare's Implantable Miniature Telescope (IMT, intraocular telescope or telescope) is indicated for monocular implantation to improve vision in eyes of patients at least 65 years of age with severe to profound vision…
- Trial name
- TES (NCT03011554)
- Testing
- Implantable Miniature Telescope (IMT)
- Where
- 14 sites in United States
- Volunteers
- 75 people
- Sponsor
- VisionCare, Inc.
Renal Insufficiency, Kidney Disease
A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.
The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when subjects have severe renal impairment or end…
- Trial name
- NCT02325024
- Testing
- Sativex
- Volunteers
- healthy volunteers welcome
- Sponsor
- GW Pharmaceuticals Ltd
Angina Pectoris, Angina Pectoris, Stable
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
- Conditions
- Angina Pectoris, Angina Pectoris, Stable, Chronic Stable Angina
- Trial name
- NCT02710435
- Testing
- Reducer System
- Where
- 25 sites in Austria, Belgium and 7 more
- Volunteers
- 400 people
- Sponsor
- Shockwave Medical, Inc.
Hemodialysis
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
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…
- Trial name
- NCT05533008
- Testing
- CR845 0.5 mcg/kg
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- Cara Therapeutics, Inc.
End Stage Renal Disease, ESRD
Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis
The goal of this clinical investigation is to asses the safety and efficacy a new sorbent-based hemodialysis device, NeoKidney® in ESRD patients treated with short daily hemodialysis.
- Trial name
- FIH Caen (NCT06024135)
- Testing
- NeoKidney
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Nextkidney S.A.
Renal Failure
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.
- Trial name
- NCT00240331
- Testing
- 10mg Rosuvastatin
- Where
- 239 sites in Australia, Austria and 23 more
- Volunteers
- 2,776 people
- Sponsor
- AstraZeneca
Uremic Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
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.
- Trial name
- NCT03422653
- Testing
- CR845 0.5 mcg/kg
- Where
- 57 sites in United States
- Volunteers
- 378 people
- Sponsor
- Cara Therapeutics, Inc.
Hyperphosphatemia, Chronic Kidney Disease, Receiving Dialysis
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease, Receiving Dialysis, ESRD (End-Stage Renal Disease), Dialysis
- Trial name
- RESPOND-2 (NCT06933472)
- Testing
- AP301, AP301 Low Dose
- Where
- 42 sites in United States, China
- Volunteers
- 264 people
- Sponsor
- Alebund Pharmaceuticals
Chronic Kidney Disease
Study to Evaluate the Prospective Payment System
To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy [End Stage Renal Disease (ESRD) Prospective…
- Trial name
- STEPPS™ (NCT01717989)
- Where
- 41 sites in United States, Puerto Rico
- Volunteers
- 2,248 people
- Sponsor
- Amgen
Type 2 Diabetes Mellitus
A Phase 3, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study of SYR-472 (25 mg) in Patients With Type 2 Diabetes Mellitus Complicated by Severe Renal Impairment or End-stage Renal Disease
The purpose of this study is to evaluate the efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes mellitus complicated by severe renal…
- Trial name
- NCT02512068
- Testing
- Trelagliptin 25 mg
- Where
- 49 sites in Japan
- Volunteers
- 107 people
- Sponsor
- Takeda
Renal Dialysis
Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment
The purpose of this study is to determine whether the use of Citrasate®, citric acid dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing hemodialysis.
- Trial name
- NCT01092455
- Testing
- Heparin N reduction
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- Randolph Quinn