Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

Kidney Diseases Clinical Trial

— RenaCARE  

Official title:

Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05846113
• Other study ID #: 20-048-TRP
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: Natera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1720
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

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).

Locations

Country	Name	City	State
United States	Liberty Dialysis/US Renal Care (USRC)	Anchorage	Alaska
United States	Western Nephrology and Metabolic Bone Disease, PC	Arvada	Colorado
United States	Southeastern Clinical Research Institute, LLC	Augusta	Georgia
United States	Northeast Clinical Research Center	Bethlehem	Pennsylvania
United States	Cleveland Clinic	Cleveland	Ohio
United States	Nephrology & Hypertension Specialists, PC (USRC)	Dalton	Georgia
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Nephrology Associates of Northern Indiana (NANI)	Fort Wayne	Indiana
United States	USRC Kidney Research (USRC)	Gallup	New Mexico
United States	Renal Consultants Medical Group (USRC)	Granada Hills	California
United States	UPMC Pinnacle Harrisburg	Harrisburg	Pennsylvania
United States	Nephrology Associates of Northern Illinois (NANI)	Hinsdale	Illinois
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Renal Care Consultants, P.C.	Johnstown	Pennsylvania
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	NYU Langone Hospital-Long Island	Mineola	New York
United States	Yale University	New Haven	Connecticut
United States	PRINE Health	New Hyde Park	New York
United States	Columbia University	New York	New York
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Kidney & Hypertension Transplant Associates	San Antonio	Texas
United States	South Texas Renal Care Group (USRC)	San Antonio	Texas
United States	Texas Kidney Care	San Antonio	Texas
United States	US Renal Care (USRC)	San Antonio	Texas
United States	US Renal Care (USRC) - Westover Hills	San Antonio	Texas
United States	California Institute of Renal Research (CIRR)/(Balboa)	San Diego	California
United States	AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers)	Tucson	Arizona
United States	George Washington Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Natera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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