RenaCARE
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-002744
Sponsor Protocol Number: 20-048-TRP
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 Chronic Kidney Disease (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)*;
- Nephropathy associated with Hypertension*;
- Cystic nephropathy*;
- Congenital nephropathy;
- Tubulointerstitial disease of unknown etiology;
- Proteinuric disease suggestive of a primary glomerulopathy by clinical evaluation;
- Early onset, 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.
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 10/6/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ziad Zoghby, M.D., M.B.A. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available