Clincosm LogoSign in Get a demo

Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

Sponsor
Natera, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05846113
Collaborator
(none)
1,720
Enrollment
31
Locations
49.8
Anticipated Duration (Months)
55.5
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1720 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
    Actual Study Start Date :
    Jun 7, 2021
    Anticipated Primary Completion Date :
    Aug 1, 2025
    Anticipated Study Completion Date :
    Aug 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Demonstrate the superiority of Renasight for supporting the diagnosis in comparison to phenotypic-specific 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. Analysis will be performed for the entire cohort as well as across different clinical categories of disease.

    2. Evaluate the ability of Renasight to change patient management. [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.

    Secondary Outcome Measures

    1. Evaluate the impact of Renasight on patient satisfaction, health knowledge and genetics literacy. [Within 6 months 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.

    2. Evaluate the impact of Renasight on family outcomes. [Within 1 year 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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):

    5. Nephropathy associated with Diabetes Mellitus (DM)*

    6. Nephropathy associated with Hypertension*

    7. Cystic nephropathy*

    8. Congenital nephropathy

    9. Tubulointerstitial disease of unknown etiology

    10. Proteinuric disease suggestive of a primary glomerulopathy by clinical evaluation

    11. Early, severe or familial hypertension

    12. Thrombotic microangiopathy

    13. Electrolyte and acid base disorder

    14. Nephrolithiasis with family history

    15. CKD of unknown cause after standard nephrological evaluation

    16. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liberty Dialysis/US Renal Care (USRC) Anchorage Alaska United States 99515
    2 AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers) Tucson Arizona United States 85718
    3 Renal Consultants Medical Group (USRC) Granada Hills California United States 91344
    4 California Institute of Renal Research (CIRR)/(Balboa) San Diego California United States 92123
    5 Western Nephrology and Metabolic Bone Disease, PC Arvada Colorado United States 80002
    6 Yale University New Haven Connecticut United States 06510
    7 George Washington Medical Faculty Associates Washington District of Columbia United States 20037
    8 Southeastern Clinical Research Institute, LLC Augusta Georgia United States 30904
    9 Nephrology & Hypertension Specialists, PC (USRC) Dalton Georgia United States 30721
    10 Nephrology Associates of Northern Illinois (NANI) Hinsdale Illinois United States 60521
    11 Nephrology Associates of Northern Indiana (NANI) Fort Wayne Indiana United States 46804
    12 Mayo Clinic Rochester Minnesota United States 55905
    13 University of Mississippi Medical Center Jackson Mississippi United States 39261
    14 Saint Barnabas Medical Center Livingston New Jersey United States 07039
    15 USRC Kidney Research (USRC) Gallup New Mexico United States 87301
    16 NYU Langone Hospital-Long Island Mineola New York United States 11501
    17 PRINE Health New Hyde Park New York United States 11042
    18 Columbia University New York New York United States 10032
    19 Cleveland Clinic Cleveland Ohio United States 44195
    20 Northeast Clinical Research Center Bethlehem Pennsylvania United States 18017
    21 Doylestown Hospital Doylestown Pennsylvania United States 18901
    22 UPMC Pinnacle Harrisburg Harrisburg Pennsylvania United States 17104
    23 Renal Care Consultants, P.C. Johnstown Pennsylvania United States 15905
    24 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    25 Einstein Medical Center Philadelphia Pennsylvania United States 19141
    26 University of Pittsburgh Medical Center (UPMC) Pittsburgh Pennsylvania United States 15261
    27 US Renal Care (USRC) San Antonio Texas United States 78202
    28 Kidney & Hypertension Transplant Associates San Antonio Texas United States 78204
    29 Texas Kidney Care San Antonio Texas United States 78207
    30 South Texas Renal Care Group (USRC) San Antonio Texas United States 78211
    31 US Renal Care (USRC) - Westover Hills San Antonio Texas United States 78251

    Sponsors and Collaborators

    • Natera, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Natera, Inc.
    ClinicalTrials.gov Identifier:
    NCT05846113
    Other Study ID Numbers:
    • 20-048-TRP
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Natera, Inc.
    Chronic Kidney Disease
    Additional relevant MeSH terms:
    Kidney Diseases

    Study Results

    No Results Posted as of May 6, 2023