Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

NCT05846113 | Unknown

• 1 other identifier: 20-048-TRP
• Study Type: interventional
• Target: 1,720
• Locations: 1 country
• Sites: 31

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.

Conditions

Kidney Diseases

Keywords

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Evaluate the impact of Renasight on patient satisfaction, health knowledge and genetics literacy.

  Within 2 years of recruitment close

• Evaluate the impact of Renasight on family outcomes.

  Within 2 years of recruitment close

Study Arms (1)

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

Diagnostic Test: Renasight

Interventions

Renasight DIAGNOSTIC_TEST

The Renasight™ 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 Renasight™ 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).

Renacare patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (31)

Liberty Dialysis/US Renal Care (USRC)

Anchorage, Alaska, 99515, United States

Location

AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers)

Tucson, Arizona, 85718, United States

Location

Renal Consultants Medical Group (USRC)

Granada Hills, California, 91344, United States

Location

California Institute of Renal Research (CIRR)/(Balboa)

San Diego, California, 92123, United States

Location

Western Nephrology and Metabolic Bone Disease, PC

Arvada, Colorado, 80002, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Southeastern Clinical Research Institute, LLC

Augusta, Georgia, 30904, United States

Location

Nephrology & Hypertension Specialists, PC (USRC)

Dalton, Georgia, 30721, United States

Location

Nephrology Associates of Northern Illinois (NANI)

Hinsdale, Illinois, 60521, United States

Location

Nephrology Associates of Northern Indiana (NANI)

Fort Wayne, Indiana, 46804, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39261, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

USRC Kidney Research (USRC)

Gallup, New Mexico, 87301, United States

Location

NYU Langone Hospital-Long Island

Mineola, New York, 11501, United States

Location

PRINE Health

New Hyde Park, New York, 11042, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Northeast Clinical Research Center

Bethlehem, Pennsylvania, 18017, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, 17104, United States

Location

Renal Care Consultants, P.C.

Johnstown, Pennsylvania, 15905, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15261, United States

Location

US Renal Care (USRC)

San Antonio, Texas, 78202, United States

Location

Kidney & Hypertension Transplant Associates

San Antonio, Texas, 78204, United States

Location

Texas Kidney Care

San Antonio, Texas, 78207, United States

Location

South Texas Renal Care Group (USRC)

San Antonio, Texas, 78211, United States

Location

US Renal Care (USRC) - Westover Hills

San Antonio, Texas, 78251, United States

Location

Related Publications (2)

• 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. 2025 Oct 29. doi: 10.1681/ASN.0000000913. Online ahead of print. No abstract available.

  PMID: 41563380 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.

  PMID: 37794564 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hoss Tabriziani, MD

  Natera, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: June 7, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)