Review and Evaluation (RenaCARE) Study

Overview

About this study

The purpose of this study is to evaluate the Renasight™ test, 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 300 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • 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 (note: can be newly diagnosed or existing patient):
    • Nephropathy associated with Diabetes Mellitus (DM)*;
    • Nephropathy associated with Hypertension*;
    • Cystic nephropathy*;
      • *Total number of patients in each of these categories will not exceed 10% of total cohort. This 10% is going to be measured by Natera (Sponsor) for the entire cohort and not per center/site.
    • Congenital nephropathy;
    • Tubulointerstitial disease of unknown etiology;
    • Proteinuric disease suggestive of a primary glomerulopathy;
    • Hematuria;
    • Early, severe or familial hypertension;
    • Thrombotic microangiopathy;
    • Electrolyte and/or acid base disorder;
    • Nephrolithiasis with family history;
    • CKD of unknown cause after standard nephrological evaluation;
    • End stage kidney disease (ESRD.

Exclusion Criteria:

  • 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.
  • Received a blood transfusion within that last 30 days of study blood draw.

Eligibility last updated 9/8/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fouad Chebib, M.D.

Contact us for the latest status

Contact information:

Justin Patri CCRP

(507) 293-3732

Patri.Justin@mayo.edu

More information

Publications

Publications are currently not available