This is a study with 2 parts. Part 1 comprises a visit to collect biological samples necessary for the molecular characterization of chronic kidney disease. Part 2 comprises an observational period of 5 visits over a period up to 8 weeks. During Part 2, baseline tests will be conducted, and urine will be collected approximately every 2 weeks for 8 weeks. Patients may participate in Part 1, Part 2, or both, and will be followed for up to 1 year consisting of data collection from the patient's medical records and home collection of urine samples every 4 months.
Study Type
OBSERVATIONAL
Enrollment
20
This is a non-interventional study
This is a non-interventional study
Aventiv Research - Phoenix
Mesa, Arizona, United States
Glendale Adventist Medical Center
Glendale, California, United States
DaVita Mojave Sage Dialysis
Victorville, California, United States
Colorado Kidney Care
Denver, Colorado, United States
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, United States
St. Clair Nephrology
Roseville, Michigan, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Clinical Research Consultants
Kansas City, Missouri, United States
DaVita Pelican Point Dialysis
Las Vegas, Nevada, United States
High Desert Nephrology
Gallup, New Mexico, United States
...and 8 more locations
Change in Urine Protein-to-Creatinine Ratio (UPCR)
Time frame: Approximately 1 year
Change in Urine Albumin-to-Creatinine Ratio (UACR)
Time frame: Approximately 1 year
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline/Biomarker collection visit
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Approximately 8 weeks
Change in Urine Biomarker: Nephrin
Time frame: Approximately 1 year
Change in Urine Biomarker: Podocin
Time frame: Approximately 1 year
Change in Urine Biomarker: Rac1
Time frame: Approximately 1 year
Change in Urine Biomarker: Synaptopodin
Time frame: Approximately 1 year
Change in Urine Biomarker: Urea
Time frame: Approximately 1 year
Change in Urine Biomarker: Other Exploratory
Time frame: Approximately 1 year
Change in Serum/Plasma Biomarker: Other Exploratory
Time frame: Approximately 8 weeks
Number of patients with genetic variants predicted to be associated with chronic kidney disease and functional consequence
DNA analysis of blood sample
Time frame: Baseline/Biomarker collection visit
Gene expression profile and phenotype of inducible pluripotent stem cell (iPSC)-generated organoids
Generation of iPSC from whole blood sample
Time frame: Baseline/Biomarker collection visit
Change from Baseline Patient-reported Assessment of FSGS Symptoms
FSGS/TR-MCD patients will assess disease symptomatology utilizing the FSGS Symptom Diary and FSGS Symptom Impact Questionnaire
Time frame: Approximately 8 weeks
Change from Baseline Patient-reported Assessment of Health Status
Patients will assess health status using the 36-Item Short Form Health Survey (SF-36)
Time frame: Approximately 8 weeks
Change from Baseline Patient-reported Assessment of Fatigue
Patients will assess the symptom of fatigue utilizing the Modified Fatigue Impact Scale
Time frame: Approximately 8 weeks
Change from Baseline Clinician-reported Assessment of Edema
Clinicians will assess edema in FSGS/TR-MCD patients using a standardized measurement of edema in FSGS/TR-MCD patients
Time frame: Approximately 8 weeks
Incidence of Untoward Medical Occurrences
Incidence of untoward medical occurrences that result in death; are life threatening; require inpatient hospitalization or prolongation of existing hospitalization; result in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; or result in an important medical event.
Time frame: Approximately 1 year
% of Patients with Change in Treatment
Change in treatment as indicated by patient medical record
Time frame: Approximately 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.