Prospective, non-randomized staged pivotal clinical study to assess the safety and performance of the Xeltis Hemodialysis Access graft: Xeltis aXess US Pivotal

Date Added
November 12th, 2025
PRO Number
Pro00145869
Researcher
MARK LONDON

List of Studies

Keywords
Kidney
Summary

This is a multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon. The alternative option is called an arterio-venous graft (AVG), where the doctor implants a synthetic/artificial tube under the patient's skin, where one end of the tube connects to a vein and the other to an artery. This tube is then used as the ‘access site' during hemodialysis. Participants with ESRD in need of vascular access, and who agree to be in this study, and also meet all the eligibility criteria for participation, will receive the Xeltis aXess graft, a type of AVG as previously described.

Institution
MUSC Health Orangeburg
Recruitment Contact
virginia anderson
803-395-3878
andersvi@musc.edu

Prospective, multicenter, observational study to evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit (WRAP North America)

Date Added
July 10th, 2025
PRO Number
Pro00144496
Researcher
MARK LONDON

List of Studies

Keywords
Kidney
Summary

Subjects with stenosis or occlusion within the dialysis outflow circuit who meet the
inclusion and exclusion criteria are intended to participate in this study. The
eligibility criteria are kept to a minimum to better represent the subject profile treated
in actual clinical practice without selecting sub-groups of particular low/high risk or
excluding certain diseases or anatomies.

Institution
MUSC Health Orangeburg
Recruitment Contact
Kristen Covington
803-395-2021
covingkr@musc.edu

A Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis, Access Cannulation Trial II (ACT II)

Date Added
May 2nd, 2025
PRO Number
Pro00142896
Researcher
MARK LONDON

List of Studies

Keywords
Kidney
Summary

Patients with End Stage Renal Disease (ESRD) need hemodialysis at least three times a week, with each session lasting up to four hours. This frequent access can cause complications like infiltration, vessel wall weakening, and vein failure. The VenaSure aims to improve this by implanting a device that reduces the need for many punctures and protects the vessel walls, extending the life of the access vein. This helps patients continue their daily lives with fewer disruptions while receiving dialysis. About 100 participants will be enrolled study-wide, with 20 at MUSC Orangeburg. Participants will be followed for 36 months.

Institution
MUSC Health Orangeburg
Recruitment Contact
virginia anderson
803-395-3878
andersvi@musc.edu

Auxora for the Treatment of AKI and Modulation of Injurious "Crosstalk" with the Lung: A Randomized Control Trial (KOURAGE)

Date Added
April 22nd, 2025
PRO Number
Pro00143675
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

This study is designed to help doctors understand how to safely - and at what dose – to give the study drug to patients suffering from acute kidney injury with accompanying acute hypoxic respiratory failure (AHRF). The study is testing Auxora (study drug) against placebo (a substance that has no medical effect).

Your chance of receiving a dose is 50% (for every 1 who receives placebo, 1 receives a dose of Auxora). This selection process is called randomization (like a ‘flip of a coin') and neither you nor your study doctor will know to which group you have been assigned. Every patient in the study will receive his/her dose of Auxora or placebo once a day, for 5 days in a row.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)

Date Added
February 12th, 2025
PRO Number
Pro00137540
Researcher
Anand Achanti

List of Studies


Keywords
Kidney
Summary

IgAN is a progressive condition that causes chronic kidney disease. Over time, some patients develop end-stage kidney disease (ESKD) requiring dialysis or kidney transplant.

The purpose of this study is to see if an investigational medication is safe and effective in the treatment of IgA nephropathy.

If you are eligible for the study and decide to participate, you will come to MUSC for study visits for about 3 years. These visits will involve blood and urine samples, questions about your health, EKGs, and physical exams. Participants will be randomized in a 1:1 ratio to receive either a weight-based IV infusion of ravulizumab or placebo for 106 weeks. Depending on your response to initial treatment, there is a possibility of additional treatment. An exploratory, open-label cohort of approximately 20 participants with eGFR 20-29 mL/min/1.73m2 may also be enrolled to expand the evidence of ravulizumab in participants with advanced kidney impairment at high risk for ESKD progression.

There is no guarantee that being in this study will help you. There is no cost to participate and compensation is available for the study visits.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

Establishment of ProNephro AKITM (NGAL) Cut off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults (EPACRA-AKI)

Date Added
January 17th, 2025
PRO Number
Pro00139273
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

The EPACRA- AKI study is a multicenter observational, non- interventional study, to determine actionable cut-off(s) for ProNephro AKITM (NGAL) assay to predict patients at risk for AKI in the general adult ICU population and subgroups of particular interest, such as sepsis or cardiac surgery patients.
Subject enrollment duration is anticipated for 12 months but might be extended or shortened depending on enrollment.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistula Study

Date Added
December 3rd, 2024
PRO Number
Pro00140475
Researcher
Cary Brewton

List of Studies

Keywords
Kidney
Summary

This multi-center, prospective, randomized, 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 the SelfWrap, a bioabsorbable perivascular wrap, for supporting surgically-created AVFs and using them for dialysis.

This study will involve approximately 200 participants. Half of the subjects in this trial will receive AVFs supported by the SelfWrap, while the other half will receive a traditional AVF alone. Participants will be followed for a duration of 36 months.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Patricia Robinson
843-674-5175
robinpat@musc.edu

A Single-blind, Phase 2, Multi-center, Randomized Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients with Hepatorenal Syndrome – Acute Kidney Injury

Date Added
November 21st, 2024
PRO Number
Pro00139091
Researcher
Don Rockey

List of Studies


Keywords
Kidney
Summary

This is a randomized, single-blind controlled, two group, multicenter trial
preceded by a safety run-in, in patients with Hepatorenal Syndrome (HRS) –
Acute Kidney Injury (HRS-AKI) to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients.

Institution
MUSC
Recruitment Contact
Jad Allam Saab
843-876-8439
allamj@musc.edu

A Phase III, Randomized, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function

Date Added
October 8th, 2024
PRO Number
Pro00138745
Researcher
Vishal Rao

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Kidney
Summary

We are doing this study to learn more about how effective, safe and tolerable an experimental drug called balcinrenone is when used in combination with dapagliflozin for treating patients with heart failure and impaired kidney function and also to better understand the studied disease and associated health problems. Dapagliflozin is an approved drug to treat patients with heart failure, chronic kidney disease and type 2 diabetes mellitus.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-876-5049
wakefila@musc.edu

A randomized, placebo-controlled, double-blind, multi-center study of the safety and efficacy of Niyad in patients undergoing continuous renal replacement therapy (CRRT) who cannot tolerate heparin or are at a higher risk for bleeding

Date Added
September 18th, 2024
PRO Number
Pro00135232
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

This is a research study to evaluate the safety and effectiveness of Niyad (nafamostat mesylate) as a blood thinner used during continuous renal replacement therapy (CRRT). CRRT is a standard treatment much like dialysis that is used to temporarily take the place of kidney function when one's kidneys are injured. Like your kidneys, CRRT helps to clean your blood and remove waste products.

Niyad is experimental which means that it is being tested and is not approved by the United States Food and Drug Administration (FDA). There is no guarantee that you will receive direct benefit as a result of your participation in this study. Possible benefits of Niyad include preventing your blood from clotting the dialysis filter so that the CRRT machine works more effectively and it also may reduce your need for a transfusion. The study results may help people in the future.

Participation voluntary and is expected to last up to 28 days. The length of time you may be exposed to Niyad is up to 7 days and safety assessments may last up to 28 days.

There will be no additional cost to you for procedures required in this research study. All routine clinical care that you would have undergone without participation in the study, including testing and procedures, will be billed to you/your insurance company. All study-related tests and procedures will be paid for by the Sponsor.

Some insurance plans will not pay for these services for people taking part in research studies. You will be responsible for any charges that your insurance does not cover including co-payments and deductibles.

Institution
MUSC
Recruitment Contact
Marcie Pregulman
(843) 792-8166
pregulma@musc.edu



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