Renasight Clinical Application, Review and Evaluation (RenaCARE) Study (RenaCARE)

This study is an open-label, multi-center study evaluating the clinical utility of Renasight in the diagnosis and management of kidney disease.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Diseases
• Intervention / Treatment: Diagnostic test: Renasight

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.

• Study Type: Interventional
• Enrollment (Actual): 1720
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99515
      • Liberty Dialysis/US Renal Care (USRC)
  • Arizona
    • Tucson, Arizona, United States, 85718
      • AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers)
  • California
    • Granada Hills, California, United States, 91344
      • Renal Consultants Medical Group (USRC)
    • San Diego, California, United States, 92123
      • California Institute of Renal Research (CIRR)/(Balboa)
  • Colorado
    • Arvada, Colorado, United States, 80002
      • Western Nephrology and Metabolic Bone Disease, PC
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington Medical Faculty Associates
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Southeastern Clinical Research Institute, LLC
    • Dalton, Georgia, United States, 30721
      • Nephrology & Hypertension Specialists, PC (USRC)
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Nephrology Associates of Northern Illinois (NANI)
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Nephrology Associates of Northern Indiana (NANI)
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39261
      • University of Mississippi Medical Center
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center
  • New Mexico
    • Gallup, New Mexico, United States, 87301
      • USRC Kidney Research (USRC)
  • New York
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital-Long Island
    • New Hyde Park, New York, United States, 11042
      • PRINE Health
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Harrisburg, Pennsylvania, United States, 17104
      • UPMC Pinnacle Harrisburg
    • Johnstown, Pennsylvania, United States, 15905
      • Renal Care Consultants, P.C.
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh Medical Center (UPMC)
  • Texas
    • San Antonio, Texas, United States, 78202
      • US Renal Care (USRC)
    • San Antonio, Texas, United States, 78204
      • Kidney & Hypertension Transplant Associates
    • San Antonio, Texas, United States, 78207
      • Texas Kidney Care
    • San Antonio, Texas, United States, 78211
      • South Texas Renal Care Group (USRC)
    • San Antonio, Texas, United States, 78251
      • US Renal Care (USRC) - Westover Hills

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Between 811 and 2000 subjects will be enrolled at up to 15 centers in the United States. Patients must have a diagnosis of kidney disease, hypertension, and/or one of the diagnosis, listed in inclusion criteria. Patients can be newly diagnosed or an existing patient.

Description

Inclusion Criteria:

• Patients must meet all the following selection criteria to be eligible for the study. Eligibility will be assessed by the investigator:

  1. 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.
  2. Able to read, understand, and provide written informed consent
  3. Willing and able to comply with the study-related procedures

  4. Diagnosis of kidney disease, and/or one of the following without any kidney biopsy (note: can be newly diagnosed or existing patient):

     1. Nephropathy associated with Diabetes Mellitus (DM)*
     2. Nephropathy associated with Hypertension*
     3. Cystic nephropathy*
     4. Congenital nephropathy
     5. Tubulointerstitial disease of unknown etiology
     6. Proteinuric disease suggestive of a primary glomerulopathy by clinical evaluation
     7. Early, severe or familial hypertension
     8. Thrombotic microangiopathy
     9. Electrolyte and acid base disorder
     10. Nephrolithiasis with family history
     11. CKD of unknown cause after standard nephrological evaluation
     12. End stage kidney disease (ESRD) *Total number of patients in each of these categories will not exceed 10% of total cohort

Exclusion Criteria:

• Patients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:

  1. Age less than 18, or greater than 65 without a family history of CKD or clinical suspicion of genetic disorder
  2. History of renal transplant
  3. Clinical features and a kidney biopsy diagnosis strongly indicative of a secondary nephropathy (e.g., diabetic nephropathy, lupus nephritis, acute kidney injury)
  4. Previously confirmed diagnosis of a hereditary kidney disease via genetic testing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Renacare patients; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Natera, Inc.
• Investigators: Principal Investigator: Hoss Tabriziani, MD, Natera, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases
• Other Study ID Numbers: 20-048-TRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No