A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease

Date Added
May 11th, 2022
PRO Number
Pro00117678
Researcher
Roberto Pisoni

List of Studies


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

This randomized, double-blind, placebo-controlled Phase 2/3 adaptive study will first evaluate two doses of VX-147 in subjects with APOL1-mediated proteinuric kidney disease for 12 weeks to select a dose for Phase 3 and subsequently evaluate the efficacy and safety of the single, selected dose in the Phase 3 portion of the study.
The study comprises three periods: screening, treatment, and follow-up. The initial treatment period for Phase 2 is 12 weeks. Subjects enrolled for Phase 2 and Phase 3 who receive the non-selected dose will switch to the Phase 3 dose in a blinded manner after the Phase 3 dose is determined. The study will complete when 187 composite clinical outcome events are accrued among subjects in Phase 2 and Phase 3 who received placebo or the Phase 3 dose and when all enrolled subjects have at least 2 years of eGFR data.

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

Translational Research Center in Lung Cancer Disparities (TRACER) Biospecimen/Pathology Core

Date Added
April 12th, 2022
PRO Number
Pro00119496
Researcher
Steven Carroll

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Keywords
Cancer, Cancer/Lung, Men's Health, Minorities, Women's Health
Summary

This is study involves a research repository which is a collection of biospecimens and information about people who have various diseases or conditions, or who receive various treatments. This research repository is being created to make sure samples are available for research on how disparities may put people at greater risk for lung cancer. People who identify as Black, African American, African, Afro and Caribbean, as well as Native Peoples and LatinX individuals with African Ancestry are at increased risk for dying from lung cancer; people who live near highways, regardless of their race or ethnicity are at risk for getting lung cancer and dying, even if they do not smoke. In this study, researchers are asking to collect and store participants' biospecimens and health information. Biospecimens are samples of human material such as urine, blood, tissue, cells, DNA, RNA, and protein. Information is defined as health and/or other health-related information (such as survey answers, etc.) associated with a condition or treatment. Participants will have their information stored in a secure database and shared with other researchers for future research studies.

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

Care Retention and Engagement of Veterans Living with HIV during the COVID-19 Pandemic

Date Added
December 1st, 2021
PRO Number
Pro00113239
Researcher
Ruth Adekunle

List of Studies

Keywords
Coronavirus, HIV / AIDS, Minorities
Summary

The COVID-19 pandemic has affected all persons, though disadvantaged populations such as persons living with HIV are likely to be disproportionally impacted by the physical, economic, and psychological toll of the global pandemic. This study aims to better understand how COVID-19 has impacted care for veterans living with HIV.

Institution
MUSC
Recruitment Contact
Ruth Adekunle
843-876-3092
adekunle@musc.edu

Social factors, epigenomics, and lupus in African American women (SELA)

Date Added
August 17th, 2021
PRO Number
Pro00112945
Researcher
Paula Ramos

List of Studies