Review and Evaluation (RenaCARE) Study

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Fouad Chebib, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Justin Patri CCRP

(507) 293-3732

Patri.Justin@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20539655

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