Intrathecal Morphine versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Ureteral Reimplantation

Date Added
June 21st, 2022
PRO Number
Pro00121082
Researcher
Natalie Barnett

List of Studies

Keywords
Adolescents, Kidney, Pediatrics, Urinary
Summary

Patients between the ages of 12 months and 11 years who are undergoing ureteral reimplantation surgery will be randomized to receive intrathecal morphine, or bilateral quadratrus lumborum block. We will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.

Institution
MUSC
Recruitment Contact
Haley Nitchie
843-792-1869
nitchie@musc.edu

A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older 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 will first evaluate two doses of VX-147 in subjects with APOL1-mediated proteinuric kidney disease for 12 weeks to select a dose for Phase 3 and subsequently evaluate the efficacy and safety of the single, selected dose in the Phase 3 portion of the study.
The study comprises three periods: screening, treatment, and follow-up. The initial treatment period for Phase 2 is 12 weeks. Subjects enrolled for Phase 2 and Phase 3 who receive the non-selected dose will switch to the Phase 3 dose in a blinded manner after the Phase 3 dose is determined. The study will complete when 187 composite clinical outcome events are accrued among subjects in Phase 2 and Phase 3 who received placebo or the Phase 3 dose and when all enrolled subjects have at least 2 years of eGFR data.

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

Precision Medicine Proof of Concept for TNF Inhibition in FSGS and Treatment Resistant Minimal Change Disease

Date Added
April 5th, 2022
PRO Number
Pro00117119
Researcher
David Selewski

List of Studies


Keywords
Kidney, Pediatrics
Summary

This research is studying the use of a drug called Humira in a small number of patients with Focal Segmental Glomerulosclerosis (FSGS) or treatment resistant Minimal Change Disease (TR-MCD). Specifically, some patients with FSGS and MCD have been shown in research studies to have overactive tumor necrosis factor (TNF) mechanisms in their kidney tissue. In these patients, high levels of urine markers called MCP1 and TIMP1 have been seen.

In this study, patients with FSGS or MCD with high levels of MCP1 and TIMP1 will be given a medication to block TNF, called Humira, to see if it reduces the urine levels of MCP1 and TIMP1. Subjects' health-related information, blood, and urine will be collected for this research study. This study may help us to develop individualized treatment options for future patients with TNF-driven FSGS or MCD.

Some of the more common risks with taking Humira include: infections, injection site reactions, headache and rash. This study may offer some benefit to subjects now by possibly reducing the amount of protein in their urine. The study may also benefit other patients in the future based on the knowledge gained. Alternatives to joining this study include treatment with steroids or other immunosuppressive medications.

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

NEPTUNE

Date Added
February 22nd, 2022
PRO Number
Pro00115978
Researcher
David Selewski

List of Studies


Keywords
Children's Health, Kidney, Pediatrics
Summary

A prospective parallel cohort study generating two groups of participants will be performed in NEPTUNE. The two groups are: (1) Cohort A which includes the FSGS/MCD Cohort; and the MN Cohort, both incipient and prevalent biopsied patients; and (2) Cohort B – a non-biopsy, treatment-naïve, pediatric cohort less than 19 years of age, cNEPTUNE. The sample size for the combined FSGS/MCD and MN Cohorts is a minimum of 800 participants, with a minimum of 375 new patients recruited under Protocol V5.0. The sample size for the second group, cNEPTUNE, will be a minimum of 200 participants. Participants will be recruited into each subgroup concurrently. All participants who meet the inclusion criteria at the participating centers will be enrolled if the participants or their legally authorized representative(s) provide comprehensive written informed consent. A recruit-to-replace strategy will be employed throughout the enrollment phase. Cohort A study visits including screening/eligibility, baseline, biopsy, and follow-up visits, and SMS texting. Study visits for Cohort B, cNEPTUNE, including screening/eligibility, baseline, follow-up visits, and SMS texting.

Institution
MUSC
Recruitment Contact
Christian Conley
843-792-1213
conleyc@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

ASTER: A PETAL Network Multi-Center Phase 2b Randomized Double-Blinded Placebo-Controlled Trial of Two Different Pharmacologic Therapies (Intravenous Vitamin C or Intravenous Acetaminophen)

Date Added
October 26th, 2021
PRO Number
Pro00115458
Researcher
Andrew Goodwin

List of Studies


Keywords
Hypertension/ High Blood Pressure, Kidney, Pulmonary
Summary

The purpose of this study is to evaluate if Vitamin C and/or Acetaminophen help with the treatment of sepsis. Participants will be given either Acetaminophen, Vitamin C, or a placebo through an IV for up to 5 days while in the ICU. The study aims to find a new approach for improving blood pressure and/ or the function of the lungs and kidneys for patients with sepsis. A maximum of 900 patients will be enrolled in the study.

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

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants with Severely Reduced Kidney Function who are Hospitalized for COVID-19"

Date Added
July 29th, 2021
PRO Number
Pro00109135
Researcher
Blaithin McMahon

List of Studies


Keywords
Coronavirus, Infectious Diseases, Kidney
Summary

The purpose of this study is to see if Remdesivir (RDV) in the presence of severely reduced kidney function, can improve the health of adults and children following hospitalization for COVID 19. The study is using Remdesivir compared to placebo infusions to determine the safety and efficacy of Remdesivir in severely reduced kidney function in COVID 19 subjects. The study is sponsored by Gilead Sciences. Patients will be randomized 2:1 to the Remdesivir or placebo. The duration of the study is 60 days.

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

Randomized Multi-Center, Subject and Evaluator Blinded, Parallel- Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared with Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study

Date Added
February 23rd, 2021
PRO Number
Pro00106547
Researcher
Marcelo Guimaraes

List of Studies


Keywords
Kidney, Liver, Surgery, Vascular
Summary

This study aims to investigate the safety and effectiveness of the Instylla Hydrogel Embolic System (HES) compared to the standard of care TAE/cTACE to treat a tumor by reducing or completely closing off the arterial blood supply to the tumor. The Instylla HES is an experimental treatment. Subjects will be evaluated for 180 days following the embolization procedure. At each visit, subjects will be asked to complete at least one quality of life questionnaire, undergo a physical assessment (vitals only), blood test to check blood cell levels, and follow-up tumor imaging. Throughout the duration of the study, subjects will be evaluated for complications or side effects that may be related to the procedure and/or Instylla HES device. This study will be conducted at up to 20 sites in the U.S. with additional sites outside of the U.S. It is anticipated that the full investigation will take approximately 2 years.

Institution
MUSC
Recruitment Contact
Elizabeth Kelley
843-792-2305
kelleyel@musc.edu