NCT05846113

Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,720 (actual)
• Sponsor: Natera, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients who are prospectively enrolled in the study will have blood or buccal swab samples sent to the Natera clinical lab for Renasight testing at the time of enrollment. Physicians will receive Renasight test results which may be used in clinical decision-making. At enrollment and at 1 month and 1 year following enrollment, clinical data will be submitted, and physician and subject questionnaires will be completed. Additional clinical follow-up and patient questionnaires may be completed at 2 and 3 years following enrollment.

Conditions

• Kidney Diseases

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-06-07
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-05-06
• Last updated: 2023-09-28

Locations

31 sites across 1 country: United States