search
Back to results

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

Primary Purpose

Kidney Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renasight
Sponsored by
Natera, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Diseases focused on measuring Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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): 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 Exclusion Criteria: 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.

Sites / Locations

  • Liberty Dialysis/US Renal Care (USRC)
  • AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers)
  • Renal Consultants Medical Group (USRC)
  • California Institute of Renal Research (CIRR)/(Balboa)
  • Western Nephrology and Metabolic Bone Disease, PC
  • Yale University
  • George Washington Medical Faculty Associates
  • Southeastern Clinical Research Institute, LLC
  • Nephrology & Hypertension Specialists, PC (USRC)
  • Nephrology Associates of Northern Illinois (NANI)
  • Nephrology Associates of Northern Indiana (NANI)
  • Mayo Clinic
  • University of Mississippi Medical Center
  • Saint Barnabas Medical Center
  • USRC Kidney Research (USRC)
  • NYU Langone Hospital-Long Island
  • PRINE Health
  • Columbia University
  • Cleveland Clinic
  • Northeast Clinical Research Center
  • Doylestown Hospital
  • UPMC Pinnacle Harrisburg
  • Renal Care Consultants, P.C.
  • University of Pennsylvania
  • Einstein Medical Center
  • University of Pittsburgh Medical Center (UPMC)
  • US Renal Care (USRC)
  • Kidney & Hypertension Transplant Associates
  • Texas Kidney Care
  • South Texas Renal Care Group (USRC)
  • US Renal Care (USRC) - Westover Hills

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renacare patients

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 26, 2023
Last Updated
September 25, 2023
Sponsor
Natera, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05846113
Brief Title
Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
Acronym
RenaCARE
Official Title
Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Natera, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
Chronic Kidney Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renacare patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Renasight
Intervention Description
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).
Primary Outcome Measure Information:
Title
Test Positive Prevalence: The frequency of positive test results across the entire cohort and within different categories of kidney disorders will be analyzed.
Description
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
Time Frame
Within 3 months of recruitment close
Title
Frequency of positive test results of Renasight compared to frequency of positive test results of phenotypic panels
Description
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.
Time Frame
Within 6 months of recruitment close
Title
Number of participants with changed treatment or clinical management and new clinical diagnoses established based on Renasight test results.
Description
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.
Time Frame
Within 3 years and 6 months of recruitment close
Secondary Outcome Measure Information:
Title
Evaluate the impact of Renasight on patient satisfaction, health knowledge and genetics literacy.
Description
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.
Time Frame
Within 2 years of recruitment close
Title
Evaluate the impact of Renasight on family outcomes.
Description
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.
Time Frame
Within 2 years of recruitment close

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoss Tabriziani, MD
Organizational Affiliation
Natera, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liberty Dialysis/US Renal Care (USRC)
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99515
Country
United States
Facility Name
AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Renal Consultants Medical Group (USRC)
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
California Institute of Renal Research (CIRR)/(Balboa)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Western Nephrology and Metabolic Bone Disease, PC
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
George Washington Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Southeastern Clinical Research Institute, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
Nephrology & Hypertension Specialists, PC (USRC)
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30721
Country
United States
Facility Name
Nephrology Associates of Northern Illinois (NANI)
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Nephrology Associates of Northern Indiana (NANI)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39261
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
USRC Kidney Research (USRC)
City
Gallup
State/Province
New Mexico
ZIP/Postal Code
87301
Country
United States
Facility Name
NYU Langone Hospital-Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
PRINE Health
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Northeast Clinical Research Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
UPMC Pinnacle Harrisburg
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17104
Country
United States
Facility Name
Renal Care Consultants, P.C.
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
US Renal Care (USRC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78202
Country
United States
Facility Name
Kidney & Hypertension Transplant Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78204
Country
United States
Facility Name
Texas Kidney Care
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
South Texas Renal Care Group (USRC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78211
Country
United States
Facility Name
US Renal Care (USRC) - Westover Hills
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

We'll reach out to this number within 24 hrs