Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
- Conditions
- Kidney Diseases
- Interventions
- Diagnostic Test: Renasight
- Registration Number
- NCT05846113
- Lead Sponsor
- Natera, Inc.
- Brief Summary
This study is an open-label, multi-center study evaluating the clinical utility of Renasight in the diagnosis and management of kidney disease.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1720
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Patients must meet all the following selection criteria to be eligible for the study. Eligibility will be assessed by the investigator:
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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.
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Able to read, understand, and provide written informed consent
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Willing and able to comply with the study-related procedures
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Diagnosis of kidney disease, and/or one of the following without any kidney biopsy (note: can be newly diagnosed or existing patient):
- Nephropathy associated with Diabetes Mellitus (DM)*
- Nephropathy associated with Hypertension*
- Cystic nephropathy*
- Congenital nephropathy
- Tubulointerstitial disease of unknown etiology
- Proteinuric disease suggestive of a primary glomerulopathy by clinical evaluation
- Early, severe or familial hypertension
- Thrombotic microangiopathy
- Electrolyte and acid base disorder
- Nephrolithiasis with family history
- CKD of unknown cause after standard nephrological evaluation
- End stage kidney disease (ESRD) *Total number of patients in each of these categories will not exceed 10% of total cohort
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Patients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:
- Age less than 18, or greater than 65 without a family history of CKD or clinical suspicion of genetic disorder
- History of renal transplant
- Clinical features and a kidney biopsy diagnosis strongly indicative of a secondary nephropathy (e.g., diabetic nephropathy, lupus nephritis, acute kidney injury)
- Previously confirmed diagnosis of a hereditary kidney disease via genetic testing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Renacare patients Renasight 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. Diagnosis of kidney disease
- Primary Outcome Measures
Name Time Method Number of participants with changed treatment or clinical management and new clinical diagnoses established based on Renasight test results. Within 3 years and 6 months of recruitment close The enrolling physician will complete baseline questionnaires, 1-month post-result questionnaires, and 1-year follow-up questionnaires. Changes to pre-result planned management as well as new diagnostic information will be assessed. Pre-result and post-result surveys will be reviewed for all subjects, regardless of test results.
Frequency of positive test results of Renasight compared to frequency of positive test results of phenotypic panels Within 6 months of recruitment close The frequency of positive test results of the Renasight panel will be compared to phenotype-specific commercial panels virtually reconstructed from the Renasight gene content. The frequency of positive test results will also be compared across different clinical categories of disease in the study population.
Test Positive Prevalence: The frequency of positive test results across the entire cohort and within different categories of kidney disorders will be analyzed. Within 3 months of recruitment close Frequency of positive test results is defined as the number of patients in a given category with a genetic finding on Renasight divided by the total number of patients in that category. Changes in diagnosis from baseline physician questionnaire to post-result physician questionnaire will be classified
- Secondary Outcome Measures
Name Time Method Evaluate the impact of Renasight on patient satisfaction, health knowledge and genetics literacy. Within 2 years of recruitment close Pre- and post-results questionnaires will be assessed for associations between genetic testing and psychological wellbeing and the impact on genetic testing on healthcare utilization. Genetic literacy pre- and post-results will be compared.
Evaluate the impact of Renasight on family outcomes. Within 2 years of recruitment close Results of the post-results survey will be analyzed to determine the number of family members who have undergone screening and diagnosis as a result of genetic testing.
Trial Locations
- Locations (31)
Southeastern Clinical Research Institute, LLC
🇺🇸Augusta, Georgia, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Pinnacle Harrisburg
🇺🇸Harrisburg, Pennsylvania, United States
Kidney & Hypertension Transplant Associates
🇺🇸San Antonio, Texas, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Renal Care Consultants, P.C.
🇺🇸Johnstown, Pennsylvania, United States
Texas Kidney Care
🇺🇸San Antonio, Texas, United States
Renal Consultants Medical Group (USRC)
🇺🇸Granada Hills, California, United States
California Institute of Renal Research (CIRR)/(Balboa)
🇺🇸San Diego, California, United States
George Washington Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Nephrology & Hypertension Specialists, PC (USRC)
🇺🇸Dalton, Georgia, United States
Nephrology Associates of Northern Indiana (NANI)
🇺🇸Fort Wayne, Indiana, United States
Nephrology Associates of Northern Illinois (NANI)
🇺🇸Hinsdale, Illinois, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
USRC Kidney Research (USRC)
🇺🇸Gallup, New Mexico, United States
NYU Langone Hospital-Long Island
🇺🇸Mineola, New York, United States
Columbia University
🇺🇸New York, New York, United States
PRINE Health
🇺🇸New Hyde Park, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Northeast Clinical Research Center
🇺🇸Bethlehem, Pennsylvania, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Western Nephrology and Metabolic Bone Disease, PC
🇺🇸Arvada, Colorado, United States
Liberty Dialysis/US Renal Care (USRC)
🇺🇸Anchorage, Alaska, United States
AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers)
🇺🇸Tucson, Arizona, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
US Renal Care (USRC)
🇺🇸San Antonio, Texas, United States
South Texas Renal Care Group (USRC)
🇺🇸San Antonio, Texas, United States
US Renal Care (USRC) - Westover Hills
🇺🇸San Antonio, Texas, United States
Yale University
🇺🇸New Haven, Connecticut, United States