A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up (CONTRAIL I)

Date Added
February 25th, 2020
PRO Number
Pro00089195
Researcher
Derek DuBay

List of Studies

Keywords
Liver, Transplant
Summary

This study is testing an investigational (not yet FDA approved) drug called CFZ533 compared to standard of care anti-rejection medications in patients who are having a Liver transplant. This study drug is being tested because it may have fewer long-term side effects than current standard therapy. This study is for first time liver transplant patients. Study drug will be administered every 2 weeks and participation will last for 2 years after transplant surgery.

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

The effect of conversion to once-daily Envarsus on the neurologic toxicity burden in liver transplant recipients

Date Added
April 9th, 2019
PRO Number
Pro00083855
Researcher
Derek DuBay

List of Studies

Keywords
Liver, Transplant
Summary

The aim of this study is to determine if a long-acting tacrolimus product can reduce the severity and incidence of several neurotoxicities commonly seen after liver transplant. The medications being used in this study are extended release tacrolimus (Envarsus) and immediate release tacrolimus (Prograf). Participants will receive SOC treatment for up to 15 days and no longer than 12 months post-transplant, and then randomized to either Envarsus or Prograf for the 6 month duration of the study. There are 9 study visits that will involve tests, exams and procedures that are both standard of care and study purposes.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-7082
rowle@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

Kidney Paired Donation Video Education Trial

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

List of Studies

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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