Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

Natera

Status: Active, not recruiting

Conditions: Kidney Diseases

Treatments: Diagnostic Test: Renasight

Study type: Interventional

Funder types: Industry

Identifiers

NCT05846113

20-048-TRP

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,720 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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:

  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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,720 participants in 1 patient group

Renacare patients

Experimental group

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

Treatment:

Diagnostic Test: Renasight