GDCN Clinical Center – Advancing Clinical Research in Primary Glomerular Diseases, Cost Reimbursable

Project: Research project

Project Details

Description

Northwestern University is part of a consortium of nephrology programs participating in a collaborative effort to establish long-term, serial observation of a cohort of 600 patients with any of four specific forms of biopsy-proven glomerulonephritis kidney disease (150 each with IgA nephropathy, focal segmental glomerulosclerosis, membranous glomerulonephritis, or minimal-change disease). Our collaborative group comprises one of four funded Participating Clinical Centers with the task to collectively recruit 2400 patients (600 with each of the four kidney diseases).
The goal of this project is to establish a biorepository of serum, plasma, urine, and DNA samples from these patients whose diagnosis and clinical course will be carefully documented. At repetitive clinic visits, interval relevant histories will be compiled, brief physical examinations performed, and blood and urine samples collected. The specific details for the clinical protocol were defined in a meeting of investigators from the four funded Participating Clinical Centers. Northwestern University plans to retain the participants we are currently following and recruit to replace over the next phase of the study. The clinical data, biological samples, and renal pathology materials will continue to be sent to the NIH/NIDDK biorepositories.
Dr. Shikha Wadhwani, the site principal investigator is an assistant professor in the division of Nephrology and Hypertension at Northwestern Medicine. She will work closely with site staff and clinical teams to ensure the enrollment of patients; Yashpal S Kanwar, MD, PhD. in pathology, to verify the biopsy diagnosis; and Patrick Fox, the primary research assistant for this study and who will be responsible for local processing of the biological samples. Dr. Wadhwani will be responsible for maintaining IRB approval of the study through the central IRB and for managing the budget/expenses.
Assurances
There will be no use of animals in this protocol.
There will be no use of hazardous materials in this protocol.
Human subjects will be studied and their blood, DNA, and urine samples will be processed for storage before shipment to the Data Coordinating Center. IRB approval is up to date.
StatusFinished
Effective start/end date7/2/185/31/19

Funding

  • University of North Carolina at Chapel Hill (511285//5UM1DK100867-06 REVISED)
  • National Institute of Diabetes and Digestive and Kidney Diseases (511285//5UM1DK100867-06 REVISED)

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