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

PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RELTECIMOD AS COMPARED TO PLACEBO IN ADDITION TO STANDARD OF CARE IN PATIENTS WITH SEPSIS-ASSOCIATED ACUTE KIDNEY INJURY (SA-AKI) Save

Date Added
April 9th, 2019
PRO Number
Pro00086843
Researcher
Heather Evans

List of Studies

Silhouette
Keywords
Infectious Diseases, Kidney
Summary

The purpose of the study is to test the effectiveness and safety of Reltecimod, an investigational drug, on patients with acute kidney injury associated with serious infections. The drug will be administered at a dose of 0.5 mg/kg as an intravenous infusion given over 10 minutes. There are a total of 11 study visits- only one of which involves IMP administration. The other nine visits are for follow-up of the participant's condition over a three month period. The majority of these visit will be completed by the end of the fist 30 days of the participants' trial timeline.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@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

Kidney Paired Donation Video Education Trial Save

Date Added
April 25th, 2018
PRO Number
Pro00075387
Researcher
Derek Dubay

List of Studies

Silhouette
Keywords
Education, Kidney, Transplant
Summary

Live donor kidney transplantation (LDKT) offers the most optimal survival and quality
of life benefit for those with late-stage chronic kidney disease. However, one-third of potential donors who volunteer to undergo evaluation on behalf of an intended recipient are blood-type or cross-match incompatibility. Kidney paired donation (KPD) was developed as a strategy to provide these incompatible donor-recipient pairs with an innovative opportunity for LDKT, yet its uptake by potential donors and their intended LDKT recipients is not optimal. In this study, we will evaluate the
effectiveness of a targeted video intervention designed to address common concerns
about KPD on the knowledge of KPD risks and benefits, KPD self-efficacy, and KPD
concerns in incompatible potential donors and their intended recipients.

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

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