Grants and Contracts Details
We understand that we will be a part of a collaboration of 33 sites that will work to collectively continue to follow up with all 598 previously enrolled patients and continue to enroll subjects in years 2-5 of CureGN 2.0. The aims of the study are to describe the disease trajectory under current clinical care, to estimate event rates for clinically meaningful outcomes, to identify and characterize clinical, histological, molecular, and genetic biomarkers that are linked to glomerular disease or to adverse outcomes among glomerular disease patients, to identify Patient Reported Outcomes (PROs, e.g., symptom burden, physical function, quality of life) associated with primary glomerular diseases. Blood and urine samples will be collected at the patients' yearly in person visit. The blood and urine will be aliquoted into cryovials per the study protocol before shipping the specimens to the NIDDK biorepository. When dictated by the protocol, RNA samples will be collected from every patient and DNA samples will be collected from patients who consent to DNA testing. All DNA and RNA samples will be shipped to Nationwide Children's Hospital for processing within 6 months of collection. Clinical data will also be collected, including subject demographics, vital signs, laboratory data, therapies, other clinical interventions, and outcomes. Remote visits will be conducted twice a year with each patient to collect medication and outcome changes. These phone calls or emails will be also used to increase retention and study involvement from patients. All data sent outside of the sites' institution will be de-identified using a specific study ID number given at subject enrollment, although dates will still be identifiable to Nationwide Children's Hospital and Arbor Research employees working on the study. Sites will de-identify all kidney biopsy slides and images before sending them to the Digital Pathology Repository (DPR) at the NIH. It is our expectation that sites maintain a 90% retention rate for all enrolled subjects.
|Effective start/end date
|6/1/20 → 5/31/24
- Research Institute at Nationwide Childrens Hospital: $68,425.00
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