Kidney DiseasesRenaCARENCT05846113
Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
A study testing Renasight in people with Kidney Diseases, run by Natera, Inc. at 31 sites in United States.
Trial summary
This study is an open-label, multi-center study evaluating the clinical utility of Renasight in the diagnosis and management of kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Renasight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,720 participants
- Where
- 31 sitesUnited States
- Study dates
- 7 Jun 2021to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all the following selection criteria to be eligible for the study. Eligibility will be assessed by the investigator:
- 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 without any kidney biopsy (note: can be newly diagnosed or existing patient):
- Nephropathy associated with Diabetes Mellitus (DM)*
Show all 17Show fewer
- Nephropathy associated with Hypertension*
- Cystic nephropathy*
- Congenital nephropathy
- Tubulointerstitial disease of unknown etiology
- Proteinuric disease suggestive of a primary glomerulopathy by clinical evaluation
- Early, severe or familial hypertension
- Thrombotic microangiopathy
- Electrolyte and acid base disorder
- Nephrolithiasis with family history
- CKD of unknown cause after standard nephrological evaluation
- End stage kidney disease (ESRD) *Total number of patients in each of these categories will not exceed 10% of total cohort
Who cannot join
- Patients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Liberty Dialysis/US Renal Care (USRC)
Anchorage, Alaska, 99515
Western Nephrology and Metabolic Bone Disease, PC
Arvada, Colorado, 80002
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, 30904
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
Cleveland Clinic
Cleveland, Ohio, 44195
Nephrology & Hypertension Specialists, PC (USRC)
Dalton, Georgia, 30721
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Nephrology Associates of Northern Indiana (NANI)
Fort Wayne, Indiana, 46804
USRC Kidney Research (USRC)
Gallup, New Mexico, 87301
Renal Consultants Medical Group (USRC)
Granada Hills, California, 91344
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17104
Nephrology Associates of Northern Illinois (NANI)
Hinsdale, Illinois, 60521
University of Mississippi Medical Center
Jackson, Mississippi, 39261
Renal Care Consultants, P.C.
Johnstown, Pennsylvania, 15905
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
NYU Langone Hospital-Long Island
Mineola, New York, 11501
Yale University
New Haven, Connecticut, 06510
PRINE Health
New Hyde Park, New York, 11042
Columbia University
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15261
Mayo Clinic
Rochester, Minnesota, 55905
US Renal Care (USRC)
San Antonio, Texas, 78202
Kidney & Hypertension Transplant Associates
San Antonio, Texas, 78204
Texas Kidney Care
San Antonio, Texas, 78207
South Texas Renal Care Group (USRC)
San Antonio, Texas, 78211
US Renal Care (USRC) - Westover Hills
San Antonio, Texas, 78251
California Institute of Renal Research (CIRR)/(Balboa)
San Diego, California, 92123
AKDHC Medical Research Services, LLC (Arizona Kidney Disease & Hypertension Centers)
Tucson, Arizona, 85718
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
This study is an open-label, multi-center study evaluating the clinical utility of Renasight in the diagnosis and management of kidney disease.
Read the 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
- Being tested
- Renasight
- Keywords
- Chronic Kidney Disease
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenasightDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Renacare patients | Experimental | 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 Receives: Diagnostic Test: Renasight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Positive Prevalence: The frequency of positive test results across the entire cohort and within different categories of kidney disorders will be analyzed.
Frequency of positive test results is defined as the number of patients in a given category with a genetic finding on Renasight divided by the total number of patients in that category. Changes in diagnosis from baseline physician questionnaire to post-result physician questionnaire will be classified
Measured: Within 3 months of recruitment close
Frequency of positive test results of Renasight compared to frequency of positive test results of phenotypic panels
The frequency of positive test results of the Renasight panel will be compared to phenotype-specific commercial panels virtually reconstructed from the Renasight gene content. The frequency of positive test results will also be compared across different clinical categories of disease in the study population.
Measured: Within 6 months of recruitment close
Number of participants with changed treatment or clinical management and new clinical diagnoses established based on Renasight test results.
The enrolling physician will complete baseline questionnaires, 1-month post-result questionnaires, and 1-year follow-up questionnaires. Changes to pre-result planned management as well as new diagnostic information will be assessed. Pre-result and post-result surveys will be reviewed for all subjects, regardless of test results.
Measured: Within 3 years and 6 months of recruitment close
Secondary outcomes (2)
Evaluate the impact of Renasight on patient satisfaction, health knowledge and genetics literacy.
Pre- and post-results questionnaires will be assessed for associations between genetic testing and psychological wellbeing and the impact on genetic testing on healthcare utilization. Genetic literacy pre- and post-results will be compared.
Measured: Within 2 years of recruitment close
Evaluate the impact of Renasight on family outcomes.
Results of the post-results survey will be analyzed to determine the number of family members who have undergone screening and diagnosis as a result of genetic testing.
Measured: Within 2 years of recruitment close
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Jun 2021
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Natera, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoss Tabriziani, MD, Principal investigator, Natera, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846113
- Sponsor's protocol ID
- 20-048-TRP
- Acronym
- RenaCARE
- Status last verified
- Sep 2023
- First submitted
- 26 Apr 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chebib FT, Wang X, Udani SM, Westemeyer M, Clark D, Zhang Z, Bloom MS, Milo Rasouly H, Kolupaeva V, Mizani MR, Dossabhoy NR, Faravardeh A, Demko ZP, Kotte S, Punj S, Chapman SL, Rabinowitz M, Schneider R, Tabriziani H, Bhorade S, Gharavi AG, Dahl NK. Genetic Testing in the Management of Adult CKD. J Am Soc Nephrol. 2026 Apr 1;37(4):777-789. doi: 10.1681/ASN.0000000913. Epub 2025 Oct 29.
PubMed 41563380Dahl 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.
PubMed 37794564
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renasight Clinical Application, Review and Evaluation (RenaCARE) Study
- ClinicalTrials.gov ID
- NCT05846113
- Acronym / sponsor ID
- RenaCARE / 20-048-TRP
- Conditions
- Kidney Diseases
- Keywords
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,720 participants (actual)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renacare patients | Experimental | Diagnostic Test: RenasightMale 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must meet all the following selection criteria to be eligible for the study. Eligibility will be assessed by the investigator:
Key exclusion criteria (5 listed)
- Patients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenasightThe 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). | Diagnostic test | Renacare patients |
Primary outcome
Test Positive Prevalence: The frequency of positive test results across the entire cohort and within different categories of kidney disorders will be analyzed.
Time frame: Within 3 months of recruitment close
Frequency of positive test results is defined as the number of patients in a given category with a genetic finding on Renasight divided by the total number of patients in that category. Changes in diagnosis from baseline physician questionnaire to post-result physician questionnaire will be classified
Frequency of positive test results of Renasight compared to frequency of positive test results of phenotypic panels
Time frame: Within 6 months of recruitment close
The frequency of positive test results of the Renasight panel will be compared to phenotype-specific commercial panels virtually reconstructed from the Renasight gene content. The frequency of positive test results will also be compared across different clinical categories of disease in the study population.
Number of participants with changed treatment or clinical management and new clinical diagnoses established based on Renasight test results.
Time frame: Within 3 years and 6 months of recruitment close
The enrolling physician will complete baseline questionnaires, 1-month post-result questionnaires, and 1-year follow-up questionnaires. Changes to pre-result planned management as well as new diagnostic information will be assessed. Pre-result and post-result surveys will be reviewed for all subjects, regardless of test results.
2 secondary outcomes
Evaluate the impact of Renasight on patient satisfaction, health knowledge and genetics literacy.
Time frame: Within 2 years of recruitment close
Evaluate the impact of Renasight on family outcomes.
Time frame: Within 2 years of recruitment close
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 41563380Chebib FT, Wang X, Udani SM, Westemeyer M, Clark D, Zhang Z, Bloom MS, Milo Rasouly H, Kolupaeva V, Mizani MR, Dossabhoy NR, Faravardeh A, Demko ZP, Kotte S, Punj S, Chapman SL, Rabinowitz M, Schneider R, Tabriziani H, Bhorade S, Gharavi AG, Dahl NK. Genetic Testing in the Management of Adult CKD. J Am Soc Nephrol. 2026 Apr 1;37(4):777-789. doi: 10.1681/ASN.0000000913. Epub 2025 Oct 29.
- Derived from this study: PubMed 37794564Dahl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoss Tabriziani, MD principal investigator
Natera, Inc.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renasight in people with Kidney Diseases, run by Natera, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Positive Prevalence: The frequency of positive test results across the entire cohort and within different categories of kidney disorders will be analyzed. (time frame: Within 3 months of recruitment close). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846113, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.