Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study

Date Added
March 19th, 2024
PRO Number
Pro00131754
Researcher
MARK LONDON

List of Studies

Keywords
Kidney
Summary

This research study is a prospective registry trial designed to evaluate the efficacy and safety of a novel decellularized human femoral artery allograft (Nexeon AVX) in the creation of vascular access for hemodialysis in patients with end stage renal disease (ESRD). Data from clinic visits will be collected for up to 2 years after treatment begins.

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

Pediatrics Biorepository for Nephrology Clinical Research

Date Added
April 20th, 2023
PRO Number
Pro00124386
Researcher
Katherine Twombley

List of Studies


Keywords
Bladder, Children's Health, Kidney, Urinary
Summary

The goal of this study is to develop a biorepository to store pediatric biospecimens from nephrology cohorts for on-going and future research studies. These studies plan to advance the state of science in the hopes to find more information that potentially leads to developing novel diagnostic approaches and identify therapeutic targets to prevent and/or treat pediatric disease involving the kidneys.

Institution
MUSC
Recruitment Contact
Katherine Twombley
843-792-8904
twombley@musc.edu

RANDOMIZED PHASE II STEREOTACTIC ABLATIVE RADIATION THERAPY (SABR) FOR METASTATIC UNRESECTED RENAL CELL CARCINOMA (RCC) RECEIVING IMMUNOTHERAPY (SAMURAI)

Date Added
March 8th, 2023
PRO Number
Pro00127408
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Kidney
Summary

This study is for patients with lymph node positive or metastatic kidney cancer that is inoperable. The purpose of the study is to see if we increase the time without a patient's kidney cancer getting worse or requiring surgery by adding radiation therapy to the usual immune therapy

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

A Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis

Date Added
March 7th, 2023
PRO Number
Pro00126501
Researcher
Diane Kamen

List of Studies


Keywords
Autoimmune disease, Drug Studies, Immune System, Inflammation, Kidney, Lupus
Summary

The purpose of this study is to determine if the investigational (not FDA approved) drug VIB4920 can be an effective treatment for patients with active Lupus Nephritis (LN).

This study will compare treatment with MMF (mycophenolate mofetil), Prednisone, plus the study medication VIB4920 to treatment with MMF and Prednisone alone.

Participants will have up to 15 scheduled visits that will involve routine monitoring of disease activity, up to two kidney biopsies, and blood and urine specimen collections. Participation in this study will last approximately 1 year and 2 months. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Stephanie Dezzutti
843-792-8997
brays@musc.edu

PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes

Date Added
August 17th, 2022
PRO Number
Pro00122367
Researcher
Harsha Karanchi

List of Studies


Keywords
Diabetes, Drug Studies, Heart, Kidney
Summary

This study will involve taking one or two medications already approved by the Food and Drug Administration (FDA) for treatment of type 2 diabetes to learn more about which diabetes medications are the best for lowering the risk of heart and kidney disease in individuals with type 2 diabetes who are at least 40 years old. Participation includes about 8 study visits over a period of 72 months, which can be performed over the phone remotely or during normal standard of care clinic visits. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
(843)-792-4675
hinsone@musc.edu

A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects with APOL1-mediated Proteinuric Kidney Disease

Date Added
May 11th, 2022
PRO Number
Pro00117678
Researcher
Roberto Pisoni

List of Studies


Keywords
Drug Studies, Genetics, Kidney, Minorities, Rare Diseases
Summary

This randomized, double-blind, placebo-controlled Phase 2/3 adaptive study involves an initial investigational blood test to determine if you have a specific variation related to kidney disease. The investigational blood test is to see if you have changes in your DNA of a gene called APOL1. People who have this gene variation may be at risk of losing their kidney function faster than others. If you have the variants (changes in DNA) you may be eligible to continue participation in the study. If you do not have the variants, you will not be eligible, and the study doctor will discuss your other options with you. If you decide to participate, there will be no cost to you and you will be compensated. This study will start by comparing two doses of VX-147 against placebo in subjects with APOL1-mediated kidney disease for 12 weeks. Subjects in Phase 2 will continue to Phase 3 once a dose for Phase 3 is selected. Then the Phase 3 dose of VX-147 will be evaluated for safety and effectiveness. If you meet the requirements and choose to take part in the study, you will be randomly assigned to a treatment group. You will not know which study treatment group you are assigned to and it is possible that you will receive placebo instead of VX-147. The study includes a screening, treatment, and follow-up period. The study will end after the last patient enrolled has completed 2 years in the study. This means some patients enrolling earlier could be in the study for up to 4 years.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial (HIKO STEC Trial)

Date Added
May 11th, 2022
PRO Number
Pro00117570
Researcher
Christopher Pruitt

List of Studies


Keywords
Kidney, Pediatrics
Summary

This research study aims to learn more about children and adolescents who have a shiga toxin-producing E. coli (STEC) infection. E. coli is a type of bacteria found in the intestines. Although most types of E. coli are harmless, some produce toxins that can make children sick. This study will assess what type of treatment is best for this infection.

Institution
MUSC
Recruitment Contact
Christian Conley
843-792-1213
conelyc@musc.edu

PD-INHIBITOR (NIVOLUMAB) AND IPILIMUMAB FOLLOWED BY NIVOLUMAB VS. VEGF TKI CABOZANTINIB WITH NIVOLUMAB: A PHASE III TRIAL IN METASTATIC UNTREATED RENAL CELL CANCER [PDIGREE]

Date Added
November 17th, 2021
PRO Number
Pro00116463
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Kidney
Summary

This study is for patients with advanced kidney cancer and the purpose is to see if by adding a drug called cabozantinib to another treatment after receiving the standard treatment can prolong their life.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

Treatment of Drug-resistant Adult and Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System

Date Added
November 26th, 2019
PRO Number
Pro00089025
Researcher
Milos Budisavljevic

List of Studies


Keywords
Blood Disorders, Kidney
Summary

A device called the "Liposorber LA-15 System" has been approved by the
United States Food and Drug Administration for treating kids with focal
segmental glomerulosclerosis (FSGS). The "Liposorber LA-15 System" can only be used if other treatment options, like drugs, don't work or can't be used,
but the kidneys are still working okay. It can also be used if the subject
has had a kidney transplant and the FSGS comes back after the
transplant. Although the Liposorber System can be used for FSGS, we
are not sure how well the Liposorber System works. So, we are doing this
study to find out how well the treatment works in adults.
In this research study, there will be up to 5 adults who have FSGS
enrolled at MUSC. Subjects will come back for up to 12 treatments over 9
weeks and then 5 visits to their study doctor over the next 2 years.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

CureGN: Cure Glomerulonephropathy

Date Added
February 20th, 2018
PRO Number
Pro00072900
Researcher
Milos Budisavljevic

List of Studies


Keywords
Kidney
Summary

If you have a glomerular disease, have had kidney biopsy in the last 5 years, are not on dialysis, and have not had a kidney transplant or was previously enrolled in the NEPTUNE study, you may be eligible to take part in this research study. The purpose of this study is to gather a group of patients with glomerular disease to create a source of information along with your kidney biopsy slides, blood, and urine samples so that researchers can easily and effectively study glomerular disease.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu



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