Racial/ethnic disparities in systemic lupus erythematosus (SLE) among women: examination of clinical factors and genetics

Date Added
August 11th, 2020
PRO Number
Pro00098592
Researcher
Mara Lennard Richard

List of Studies


Keywords
Autoimmune disease, Ethnicity and Disease, Genetics, Kidney, Lupus, Women's Health
Summary

Systemic lupus erythematosus (SLE) also known as lupus is a complex autoimmune disorder where the immune system attacks itself instead of external pathogens that can cause disease like bacteria or viruses. The large majority of SLE patients are women. The purpose of this study is to better understand how SLE affects overall patient health in women and expression of genes linked to the development of SLE. Part of this study involves collection of a blood sample at a single visit to test expression of genes linked to SLE. This study will compare demographic and clinical characteristics and genetic differences among women with SLE from three racial/ethnic groups. Better understanding of racial/ethnic differences in health and genetic expression of SLE could help reduce poor disease outcomes such as kidney or heart disease. Results will help us learn more about differences in SLE health across different racial/ethnic backgrounds and will guide medical care.

Institution
MUSC
Recruitment Contact
Jonathan Flume
843-792-3926
jof63@musc.edu

A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX‐147 in Adults with APOL1-mediated Focal Segmental Glomerulosclerosis

Date Added
July 21st, 2020
PRO Number
Pro00099956
Researcher
Roberto Pisoni

List of Studies


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

The study is an open-label study to determine the safety and efficacy of VX-147-101 in subjects who have APOLI dependent FSGS. The study comprises three periods: screening, treatment, and follow-up. The study includes a screening visit to determine if you have the APOLI gene. Participation in this study will last approximately 17 weeks. Participants may choose to participate in an off-treatment observation for up to 12 additional weeks.

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

A Study of the Prevalence of Apolipoprotein L1(APOL1) Alleles Among Individuals With Proteinuric Kidney Disease Who Are of Recent African Ancestry or Geographic Origin

Date Added
June 9th, 2020
PRO Number
Pro00098923
Researcher
Roberto Pisoni

List of Studies


Keywords
Genetics, Kidney, Minorities, Rare Diseases
Summary

The purpose of the study is to test to see if people with Focal Segmental Glomerulosclerosis (FSGS) have a genetic mutation (changes in DNA) so we can learn more about this disease. FSGS is a disease in which scar tissue develops on the parts of the kidneys that filter waste out of the blood. The FSGS in potential participants will be identified through previous kidney biopsy results in medical records and previous urine sample analysis results. The study will also help find people with a genetic mutation who may be interested in participating in future research studies.

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

Reducing Disparities in Living Donation Among African Americans

Date Added
January 2nd, 2020
PRO Number
Pro00092908
Researcher
Derek DuBay

List of Studies


Keywords
Diabetes, Hypertension/ High Blood Pressure, Kidney, Transplant
Summary

Kidney donation from a living donor provides the kidney recipient with the best chance of a longterm survival of the transplanted kidney. White End Stage Renal Disease (ESRD) patients are 4 times more likely to recieve a living donor kidney than are African American (AA) ESRD patients. There are many reasons for this disparity in obtaining the benefits of living donation for AAs, including lack of knowledge regarding the living donation process. This study will provide a web-based educational intervention to overcome this knowledge deficiency with the hope that there will be an increase in patient interest in living donation which will result in more living donation kidney transplant inquiries by patients' family or friends.

Institution
MUSC
Recruitment Contact
Thomas Morinelli
843-792-5405
morinelt@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

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Patients with IGA Nephropathy

Date Added
July 23rd, 2019
PRO Number
Pro00085871
Researcher
Anand Achanti

List of Studies


Keywords
Autoimmune disease, Inflammation, Kidney
Summary

The study is using cemdisiran compared to placebo injections to determine the safety and efficay of cemdisiran in treating IgA Nephropathy. The study includes a screening period (up to 90 days), 8 month treating period, and 52 week Open Label extension period. Injections occur monthly during the treatment period. Patients will be randomized 2:1 to the cemdisiran or placebo arms.

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

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (Artemis-IGAN)

Date Added
May 14th, 2019
PRO Number
Pro00083397
Researcher
Anand Achanti

List of Studies


Keywords
Drug Studies, Kidney
Summary

This study will use a new investigational study drug called OMS721 in people with Immunoglobulin A (IgA) Nephropathy. OMS721 is an antibody, which is a type of protein that can bind to substances in the body. OMS721 is being studied because it blocks a key enzyme (a protein that causes specific chemical changes in the body) in the blood that may be responsible for causing the damage in IgA Nephropathy.
The study is approximately 23 visits over a period of 3 years. The study drug is administered via a 30-minute intravenous infusion once a week for 12 weeks. You will then be evaluated to determine your response to the drug and followed-up with regularly. Possible re-treatment is determined by the study doctor.

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

Clinical Evaluation of a Vascular Venous Anastomotic Connector for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis [InterGraft Study]

Date Added
April 23rd, 2019
PRO Number
Pro00087325
Researcher
Vinayak Rohan

List of Studies


Keywords
Kidney
Summary

The InterGraft Vascular Venous Anastomotic Connector (VIG) was developed for minimally invasive anastomosis (connection) of a vein to a standard, currently sold synthetic graft for hemodialysis. The VIG is designed with a nitinol (metal) frame that is covered with a plastic material called expanded polytetrafluoroethylene, or ePTFE. The ‘vein end' of the VIG is placed within the vein using a special catheter delivery system that is inserted into the vein through a small needle puncture. The ‘graft end' of the VIG is fitted into the graft that is placed under the skin using standard methods. The purpose of this research study is to determine the safety and effectiveness of InterGraft Venous Anastomotic Connector for connecting a hemodialysis graft to a vein.

Institution
MUSC
Recruitment Contact
Tamara Jenkins
843-792-1851
saundert@musc.edu

APOL1 Long-term kidney transplantation outcomes network (APOLLO)

Date Added
February 19th, 2019
PRO Number
Pro00084947
Researcher
Derek DuBay

List of Studies


Keywords
Kidney, Transplant
Summary

Expression of APOL1 gene variants have been associated with higher likelihood of end stage renal disease in African Americans. In addition, kidney transplant recipients who have received a donated kidney from an African American expressing APOL1 variants have poorer outcomes with earlier transplanted kidney failure. This study will examine the occurance of the APOL1 gene variants in all African American donated kidneys, deceased and living, and African American recipients and recipients of African American donated kidneys, and to correlate the expression of these variants with outcome of the transplanted kidney and the kidney function of African American living donors. Samples of patients blood and urine will be acquired to measure the expression of the APOLO1 gene variants and associated kidney function, respectively.

Institution
MUSC
Recruitment Contact
Thomas Morinelli
8437925405
morinelt@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF QPI-1002 FOR THE PREVENTION OF MAJOR ADVERSE KIDNEY EVENTS (MAKE) IN SUBJECTS AT HIGH RISK FOR ACUTE KIDNEY INJURY (AKI) FOLLOWING CARDIAC SURGERY

Date Added
September 4th, 2018
PRO Number
Pro00080148
Researcher
Marc Katz

List of Studies


Keywords
Drug Studies, Heart, Kidney, Surgery
Summary

The purpose of this study is to test whether the study drug (QPI-1002) prevents Major Adverse Kidney Events (MAKE) after heart surgery in adult patients who are at high risk of developing Acute Kidney Injuries (AKI). This study is a one-time infusion of the study drug (QPI-1002) with follow-up visits lasting for one year.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu



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