Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

Status unconfirmed · Not applicable

Conditions studied: Kidney Diseases

In brief

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

Key facts

Study ID

NCT05846113

Run by

Natera, Inc.

People needed

1720

Starts

2021-06-07

Expected to finish

2025-08-01

Last updated by the study team

2023-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.