Multi-Center Research Studies | UNC Kidney Center

Glomerular Disease Collaborative Network (GDCN)

Established in 1985, the GDCN enhances communication and fosters collaborative research between community nephrology clinics and the University of North Carolina at Chapel Hill School of Medicine. Its central mission is to better understand the causes, pathogenesis, and treatment of glomerular diseases through long-term patient engagement and data collection. Today, the GDCN includes a robust network of over 300 participating clinics and academic sites across the southeastern United States and beyond.

This network of 16 disease-specific registries is designed to enroll patients at the onset of glomerular disease, track disease progression and outcomes over the patient’s lifetime and support recruitment for focused clinical and translational studies.

These registries allow the GDCN to invite patients to participate in observational studies, biological sample collections (blood, urine), surveys and interviews, treatment trials (recruitment is physician-mediated, not patient-initiated).

The current GDCN enrollment to date includes 7,151 living participants with signed informed consent. The GDCN biorepository contains over 38,000 unique samples on 3,838 participants and more than 170,000 aliquots such as DNA, RNA, serum, plasma, urine, and cells.

CureGN

UNC is an enrolling site and Participating Clinical Center in the Cure Glomerulonephropathy Network (CureGN), a longitudinal, multicenter cohort study of glomerular disease patients funded by the National Institutes of Health (NIH). The CureGN project aims to recruit and follow 2,400 children and adults with minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), membranous nephropathy (MN) or IgA nephropathy/vasculitis (IgAN/IgAV) and provide an infrastructure to allow research that will answer the questions commonly asked by patients that we are still unable to adequately answer. Since 2014, CureGN represents one of the largest observational cohort studies of adults and children with glomerular diseases and has continued to gain valuable information to better understand the cause of disease, response to therapy, and disease progression of glomerular diseases.

Participants are recruited from each of the four Participating Clinical Center (PCC) networks: Columbia University, Pediatric Nephrology Research Consortium (PNRC), University of North Carolina (UNC), and University of Pennsylvania (PENN). As one of the 4 PCCs, the UNC Kidney Center oversees eight sites within the consortia. The four PCCs serve as clinical center hubs that coordinate the clinical sites in their CureGN duties. PCC hubs have primary responsibility for managing their associated clinical sites. They are responsible for participant enrollment, maintaining outstanding subject retention, and obtaining data and biospecimens of high quality. PCC administration directly oversees study coordinator training, and local regulatory and financial management.

CureGN Diabetes

UNC is an enrolling site and coordinating center for CureGN-Diabetes, an ancillary study to CureGN, that seeks to understand how diabetes influences the diagnosis, treatment, and outcomes of glomerular disease. It is a multicenter, prospective cohort study, targeting an enrollment of 300 adults with prevalent type 1 or type 2 diabetes and minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), or membranous nephropathy (MN). CureGN-Diabetes is funded by the National Institutes of Health (NIH).

The CureGN-Diabetes consortium has 3 cores: (i) clinical (9 sites; coordinated at the University of North Carolina, Columbia University and the University of Pennsylvania), (ii) pathology (coordinated at Cedars- Sinai Medical Center), and (iii) data coordination (University of North Carolina, University of Michigan). A unique feature of CureGN-Diabetes is that it leverages data from CureGN and the NIH/NIDDK funded NEPhrotic syndrome sTUdy NEtwork (NEPTUNE) as well as an industry-academia collaboration, the Transformative Research In DiabEtic NephropaThy (TRIDENT) study.

NEPTUNE

UNC is one of 31 participating sites in the Nephrotic Syndrome Study Network (NEPTUNE), a multi-year, multi-site collaborative study that conducts clinical and translational research on Nephrotic Syndrome and Alport syndrome. NEPTUNE captures clinical data, patient-reported outcomes, kidney biopsy images and tissue, blood, and urine samples from study participants. Data and bio samples are utilized to investigate the underlying biology of the diseases within each of our study participants. Since its inception, NEPTUNE has taken a precision medicine approach to address the heterogeneity of nephrotic syndrome through discovery and innovation that considers the individual differences in the underlying biology of disease.

UNC is also participating in NEPTUNE MATCH, a study that gives participants information about which clinical trials may be a “match” to them by using their individual research data and samples collected from the NEPTUNE study. NEPTUNE Match takes individual participant data from their participation in the NEPTUNE study to better understand what is causing their kidney disease and attempts to share how they match to participating clinical trials. Because different clinical trials offer different treatments, some of the treatments offered may better target the underlying biology, or cause, of the participant’s kidney disease.