Reducing Disparities in Living Donation Among African Americans Save

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

List of Studies

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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 Save

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

List of Studies


Profiles_link
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 Save

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

List of Studies


Profiles_link
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
Kellean Van Cleef
8437928166
vancleef@musc.edu

Clinical Assessment of a novel non-invasive assay for diagnosing recurrent focal and segmental glomerulosclerosis Save

Date Added
July 5th, 2019
PRO Number
Pro00089185
Researcher
Deepak Nihalani

List of Studies


Profiles_link
Keywords
Kidney
Summary

This study will test the clinical readiness of a novel cell-based approach to develop diagnostic kit for detecting a rare form of glomerular disease known as recurrent focal and segmental glomerulosclerosis (rFSGS). This assay will be highly significant in identifying FSGS patients that are destined to loose renal graft following renal transplant.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@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) Save

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

List of Studies


Profiles_link
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
Kellean Van Cleef
843-792-8166
vancleef@musc.edu

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

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

List of Studies

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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) Save

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

List of Studies

Silhouette
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 Save

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

List of Studies

Silhouette
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

Immune response to pneumococcal vaccination in aging renal transplant recipients Save

Date Added
June 19th, 2018
PRO Number
Pro00077548
Researcher
Maria anna Westerink

List of Studies

Silhouette
Keywords
Aging, Diabetes, Geriatrics, Healthy Volunteer Studies, Hypertension/ High Blood Pressure, Immune System, Kidney, Transplant, Vaccine
Summary

We will study how well the relatively new FDA approved pneumonia vaccine can protect older renal transplant recipients against pneumococcal illness. We will specifically study the group of renal transplants in whom the cause of renal failure was either diabetes mellitus II and/or hyoertension. We will compare the findings against those we find in younger renal transplant recipients, older healthy individuals and older persons with diabetes but normal kidney function. Healthy younger individuals will serve as controls for optimal vaccine response.

Institution
MUSC
Recruitment Contact
Myroslawa Happe
843-792-2218
soloshch@musc.edu

Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation Save

Date Added
May 18th, 2018
PRO Number
Pro00078154
Researcher
Prabhakar Baliga

List of Studies


Profiles_link
Keywords
Kidney, Transplant
Summary

The House Calls (HC) program is an education study to address needs of minority end stage renal disease (ESRD) patients and their immediate support network to promote living kidney donation. It requires a HC educator to give a 60-90 minute education session in the patient's home or common location. The study is 3 years long and will comprise of 374 Black end stage renal disease patients who are on the kidney transplant waitlist or are being evaluated as waitlist candidates. Participants will be randomized to a usual care arm, a HC arm, or a HC plus a twice a week support mentor (via National Kidney Foundation) who will be in contact every two weeks. This study will recruit patients from Beth Israel Deaconess Medical Center in Boston, MA and the Medical University of South Carolina in SC.

Institution
MUSC
Recruitment Contact
John Sieverdes
843-792-1235
sieverde@musc.edu

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