ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination with Ipilimumab or Cabozantinib in Participants with Advanced Renal Cell Carcinoma (RCC)

Date Added
March 24th, 2026
PRO Number
Pro00150045
Researcher
Thai Ho

List of Studies

Keywords
Cancer, Drug Studies, Kidney, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with diagnosed with unresectable, locally advanced, recurrent or metastatic renal cell carcinoma (RCC). The study is testing investigational drugs called pumitamig."Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to evaluate the safety and tolerability, and to determine the recommended phase 2 dose (RP2D), of pumitamig administered in combination with ipilimumab or cabozantinib. The study drug is given by infusion. Participants in this study can expect to be in this study for about 4 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT) (BXU558476)

Date Added
March 10th, 2026
PRO Number
Pro00148140
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

The purpose of this research study is to confirm the safety of the study drug (Prismocitrate 18) and the study device for patients with acute kidney injury receiving a type of dialysis treatment known as Continuous Renal replacement Therapy (CRRT). When a patient receives CRRT, a blood thinner (also known as an "anticoagulant") is frequently given. In the United States (U.S.), an anticoagulant called, Heparin, is commonly used for CRRT. Some patients have a high risk of bleeding and cannot be given heparin, because it can cause harm to them. For these patients, an anticoagulant, called citrate, can be used. The study drug being tested contains citrate. The study drug works as an anticoagulant and may also help cleanse your blood during the CRRT treatment.

Institution
MUSC
Recruitment Contact
Kayla Adler
(843) 792-0965
recruitment@musc.edu

A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune-complex-mediated membranoproliferative glomerulonephritis (IC-MPGN)

Date Added
February 13th, 2026
PRO Number
Pro00147594
Researcher
Prince Anand

List of Studies

Keywords
Kidney, Rare Diseases
Summary

The purpose of this Phase III study is to evaluate the efficacy and safety of iptacopan compared to placebo (both administered in combination with standard of care) in adult participants aged at least 18 years to ≤ 60 years and adolescents (12-17 years in non-EU countries and 16-17 years in EU countries) with idiopathic IC-MPGN. The study aims to demonstrate a reduction in proteinuria and stabilization in estimated glomerular filtration rate (eGFR) in participants treated with iptacopan compared to placebo. Change in patient-reported fatigue will also be evaluated. Alternative complement pathway (AP) dysregulation is believed to underlie the clinical manifestations and progression of IC-MPGN. Serum complement (C3) and other complement pathway biomarkers will be assessed to demonstrate that iptacopan reduces AP activity and targets the underlying cause of disease.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Darann Wiegand
803-286-1385
Wiegandd@musc.edu

EndoForce Post Approval Study

Date Added
December 11th, 2025
PRO Number
Pro00147536
Researcher
MARK LONDON

List of Studies

Keywords
Kidney
Summary

The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.

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

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

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



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