Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
Sponsored by Natera, Inc.
About this trial
Last updated 2 years ago
Study ID
20-048-TRP
Status
Active, not recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 4 years ago
What is this trial about?
This study is an open-label, multi-center study evaluating the clinical utility of
Renasight in the diagnosis and management of kidney disease.
What are the participation requirements?
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.