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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renacare patients | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renasight | Diagnostic Test | The Renasightâ„¢ test is a next generation sequencing (NGS) gene mutation assay for patients with chronic kidney disease (CKD) which utilizes genomic DNA from patient blood or buccal swab samples to analyze over 380 genes that are associated with autosomal dominant, autosomal recessive and X-linked disorders. Patients undergoing Renasightâ„¢ testing are offered optional genetic information sessions in addition to their test results. RenasightTM is a commercially available Laboratory Developed Test (LDT) certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). |
| Measure | Description | Time Frame |
|---|---|---|
| Test Positive Prevalence: The frequency of positive test results across the entire cohort and within different categories of kidney disorders will be analyzed. | 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 | Within 3 months of recruitment close |
| Frequency of positive test results of Renasight compared to frequency of positive test results of phenotypic panels | 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. | Within 6 months of recruitment close |
| Number of participants with changed treatment or clinical management and new clinical diagnoses established based on Renasight test results. | 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. | Within 3 years and 6 months of recruitment close |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the impact of Renasight on patient satisfaction, health knowledge and genetics literacy. | 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. | Within 2 years of recruitment close |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Hoss Tabriziani, MD | Natera, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liberty Dialysis/US Renal Care (USRC) | Anchorage | Alaska | 99515 | United States | ||
| AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41563380 | Derived | Chebib FT, Wang X, Udani SM, Westemeyer M, Clark D, Zhang Z, Bloom MS, Milo Rasouly H, Kolupaeva V, Mizani MR, Dossabhoy NR, Faravardeh A, Demko ZP, Kotte S, Punj S, Chapman SL, Rabinowitz M, Schneider R, Tabriziani H, Bhorade S, Gharavi AG, Dahl NK. Genetic Testing in the Management of Adult CKD. J Am Soc Nephrol. 2026 Apr 1;37(4):777-789. doi: 10.1681/ASN.0000000913. Epub 2025 Oct 29. | |
| 37794564 |
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|
| Evaluate the impact of Renasight on family outcomes. | 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. | Within 2 years of recruitment close |
| Tucson |
| Arizona |
| 85718 |
| United States |
| Renal Consultants Medical Group (USRC) | Granada Hills | California | 91344 | United States |
| California Institute of Renal Research (CIRR)/(Balboa) | San Diego | California | 92123 | United States |
| Western Nephrology and Metabolic Bone Disease, PC | Arvada | Colorado | 80002 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| George Washington Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Southeastern Clinical Research Institute, LLC | Augusta | Georgia | 30904 | United States |
| Nephrology & Hypertension Specialists, PC (USRC) | Dalton | Georgia | 30721 | United States |
| Nephrology Associates of Northern Illinois (NANI) | Hinsdale | Illinois | 60521 | United States |
| Nephrology Associates of Northern Indiana (NANI) | Fort Wayne | Indiana | 46804 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39261 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| USRC Kidney Research (USRC) | Gallup | New Mexico | 87301 | United States |
| NYU Langone Hospital-Long Island | Mineola | New York | 11501 | United States |
| PRINE Health | New Hyde Park | New York | 11042 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Northeast Clinical Research Center | Bethlehem | Pennsylvania | 18017 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania | 17104 | United States |
| Renal Care Consultants, P.C. | Johnstown | Pennsylvania | 15905 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15261 | United States |
| US Renal Care (USRC) | San Antonio | Texas | 78202 | United States |
| Kidney & Hypertension Transplant Associates | San Antonio | Texas | 78204 | United States |
| Texas Kidney Care | San Antonio | Texas | 78207 | United States |
| South Texas Renal Care Group (USRC) | San Antonio | Texas | 78211 | United States |
| US Renal Care (USRC) - Westover Hills | San Antonio | Texas | 78251 | United States |
| Derived |
| Dahl NK, Bloom MS, Chebib FT, Clark D, Westemeyer M, Jandeska S, Zhang Z, Milo-Rasouly H, Kolupaeva V, Marasa M, Broumand V, Fatica RA, Raj DS, Demko ZP, Marshall K, Punj S, Tabriziani H, Bhorade S, Gharavi AG. The Clinical Utility of Genetic Testing in the Diagnosis and Management of Adults with Chronic Kidney Disease. J Am Soc Nephrol. 2023 Dec 1;34(12):2039-2050. doi: 10.1681/ASN.0000000000000249. Epub 2023 Oct 5. |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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