Northeast Clinical Research Center | Bethlehem, PA
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This study is an open-label, multi-center study evaluating the clinical utility of Renasight in the diagnosis and management of kidney disease.
Full description
Patients who are prospectively enrolled in the study will have blood or buccal swab samples sent to the Natera clinical lab for Renasight testing at the time of enrollment. Physicians will receive Renasight test results which may be used in clinical decision-making. At enrollment and at 1 month and 1 year following enrollment, clinical data will be submitted, and physician and subject questionnaires will be completed. Additional clinical follow-up and patient questionnaires may be completed at 2 and 3 years following enrollment.
Enrollment
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Inclusion criteria
Patients must meet all the following selection criteria to be eligible for the study. Eligibility will be assessed by the investigator:
Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF). If over the age of 65, patient must have a family history of CKD or clinical suspicion of genetic disorder.
Able to read, understand, and provide written informed consent
Willing and able to comply with the study-related procedures
Diagnosis of kidney disease, and/or one of the following without any kidney biopsy (note: can be newly diagnosed or existing patient):
Exclusion criteria
Patients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:
Primary purpose
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Interventional model
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1,720 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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