Clinical trial NCT05846113: Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
Official title: Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Diseases
Keywords: Chronic Kidney Disease
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 1720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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:

  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.

Primary outcomes:
measure: Test Positive Prevalence: The frequency of positive test results across the entire cohort and within different categories of kidney disorders will be analyzed.
timeFrame: Within 3 months of recruitment close
measure: Frequency of positive test results of Renasight compared to frequency of positive test results of phenotypic panels
timeFrame: Within 6 months of recruitment close
measure: Number of participants with changed treatment or clinical management and new clinical diagnoses established based on Renasight test results.
timeFrame: Within 3 years and 6 months of recruitment close
Secondary outcomes:
measure: Evaluate the impact of Renasight on patient satisfaction, health knowledge and genetics literacy.
timeFrame: Within 2 years of recruitment close
measure: Evaluate the impact of Renasight on family outcomes.
timeFrame: Within 2 years of recruitment close
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Liberty Dialysis/US Renal Care (USRC)
state: Alaska
city: Tucson
country: United States
facility: AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers)
state: Arizona
city: Granada Hills
country: United States
facility: Renal Consultants Medical Group (USRC)
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research (CIRR)/(Balboa)
state: California
city: Arvada
country: United States
facility: Western Nephrology and Metabolic Bone Disease, PC
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: George Washington Medical Faculty Associates
state: District of Columbia
city: Augusta
country: United States
facility: Southeastern Clinical Research Institute, LLC
state: Georgia
city: Dalton
country: United States
facility: Nephrology & Hypertension Specialists, PC (USRC)
state: Georgia
city: Hinsdale
country: United States
facility: Nephrology Associates of Northern Illinois (NANI)
state: Illinois
city: Fort Wayne
country: United States
facility: Nephrology Associates of Northern Indiana (NANI)
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Gallup
country: United States
facility: USRC Kidney Research (USRC)
state: New Mexico
city: Mineola
country: United States
facility: NYU Langone Hospital-Long Island
state: New York
city: New Hyde Park
country: United States
facility: PRINE Health
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Pinnacle Harrisburg
state: Pennsylvania
city: Johnstown
country: United States
facility: Renal Care Consultants, P.C.
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: San Antonio
country: United States
facility: US Renal Care (USRC)
state: Texas
city: San Antonio
country: United States
facility: Kidney & Hypertension Transplant Associates
state: Texas
city: San Antonio
country: United States
facility: Texas Kidney Care
state: Texas
city: San Antonio
country: United States
facility: South Texas Renal Care Group (USRC)
state: Texas
city: San Antonio
country: United States
facility: US Renal Care (USRC) - Westover Hills
state: Texas
Study officials:
affiliation: Natera, Inc.
name: Hoss Tabriziani, MD
role: PRINCIPAL_INVESTIGATOR
References: