Renasight Clinical Application, Review and Evaluation (RenaCARE) Study

NCT ID: NCT05846113

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2025-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Renacare patients

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.

Diagnosis of kidney disease

Group Type: EXPERIMENTAL

Renasight

Intervention Type: DIAGNOSTIC_TEST

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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients must meet all the following selection criteria to be eligible for the study. Eligibility will be assessed by the investigator:

1. 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.

2. Able to read, understand, and provide written informed consent

3. Willing and able to comply with the study-related procedures

4. Diagnosis of kidney disease, and/or one of the following without any kidney biopsy (note: can be newly diagnosed or existing patient):

1. Nephropathy associated with Diabetes Mellitus (DM)*

2. Nephropathy associated with Hypertension*

3. Cystic nephropathy*

4. Congenital nephropathy

5. Tubulointerstitial disease of unknown etiology

6. Proteinuric disease suggestive of a primary glomerulopathy by clinical evaluation

7. Early, severe or familial hypertension

8. Thrombotic microangiopathy

9. Electrolyte and acid base disorder

10. Nephrolithiasis with family history

11. CKD of unknown cause after standard nephrological evaluation

12. End stage kidney disease (ESRD) *Total number of patients in each of these categories will not exceed 10% of total cohort

Exclusion Criteria

• Patients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:

1. Age less than 18, or greater than 65 without a family history of CKD or clinical suspicion of genetic disorder

2. History of renal transplant

3. Clinical features and a kidney biopsy diagnosis strongly indicative of a secondary nephropathy (e.g., diabetic nephropathy, lupus nephritis, acute kidney injury)

4. Previously confirmed diagnosis of a hereditary kidney disease via genetic testing.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Natera, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hoss Tabriziani, MD

Role: PRINCIPAL_INVESTIGATOR

Natera, Inc.

Locations

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

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

US Renal Care (USRC)

San Antonio, Texas, United States

Kidney & Hypertension Transplant Associates

San Antonio, Texas, United States

Texas Kidney Care

San Antonio, Texas, United States

South Texas Renal Care Group (USRC)

San Antonio, Texas, United States

US Renal Care (USRC) - Westover Hills

San Antonio, Texas, United States

Countries

United States

References

Dahl NK, Bloom MS, Chebib FT, Clark D, Westemeyer M, Jandeska S, Zhang Z, Milo-Rasouly H, Kolupaeva V, Marasa M, Broumand V, Fatica RA, Raj DS, Demko ZP, Marshall K, Punj S, Tabriziani H, Bhorade S, Gharavi AG. The Clinical Utility of Genetic Testing in the Diagnosis and Management of Adults with Chronic Kidney Disease. J Am Soc Nephrol. 2023 Dec 1;34(12):2039-2050. doi: 10.1681/ASN.0000000000000249. Epub 2023 Oct 5.

Reference Type: DERIVED

PMID: 37794564 (View on PubMed)

Other Identifiers

20-048-TRP

Identifier Type: -

Identifier Source: org_study_id