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Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

NCT05846113 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1720

Last updated 2023-09-28

No results posted yet for this study

Summary

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

Conditions

Interventions

DIAGNOSTIC_TEST

Renasight

The Renasight™ test is 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 380 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. RenasightTM is a commercially available Laboratory Developed Test (LDT) certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA).

Sponsors & Collaborators

  • Natera, Inc.

    lead INDUSTRY

Principal Investigators

  • Hoss Tabriziani, MD · Natera, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05846113 on ClinicalTrials.gov