On-Going Clinical Studies Our Friendly Study Coordinators Lisandra Ninonuevo William Paredes Cynthia Rivera Sara Saini Jordan Nacimba Sally Duran Summary of Study Key Points Sugar N Salt POSIBIL 6E SKD TRIDENT study: Patients with diabetes undergoing kidney biopsy Physical function in CKD: Patients with CKD stage 4 or 5 Vertex VX19 NEN 801: Patients with FSGS or non-diabetic CKD Calciprotein Particles and Aortic Micro-calcification in Kidney Disease Cellular interactions in vascular calcification: non-diabetic patients on hemodialysis Sugar N Salt Summary: This study is testing the effectiveness and safety of sotagliflozin in slowing kidney function decline in persons with type 1 diabetes and moderate to severe diabetic kidney disease. Principal investigator: Dr. Matthew Abramowitz Major eligibility criteria: Type 1 diabetes. POSIBIL 6E SKD Summary: This study is testing the efficacy of an anti-IL-6 monoclonal antibody for reducing cardiovascular events in patients receiving maintenance dialysis. Principal investigator: Dr. Matthew Abramowitz Major eligibility criteria: Adults receiving hemodialysis or peritoneal dialysis Preserving Physical Function in Patients with Kidney Disease Summary: This study seeks to determine whether muscle scarring (called fibrosis) is partly responsible for the decline in physical function that often occurs in people with kidney disease, and whether dialysis helps to reverse this process. We also hope to identify a signal that can be used in the future to identify individuals who may experience this improvement after starting dialysis. Principal investigator: Dr. Matthew Abramowitz Major eligibility criteria: Age 50-80, CKD stage 4 or 5 (not receiving dialysis), able to walk without assistance (walking aids such as canes are permitted). Please email bill.paredes@einsteinmed.org or sally.duran@einsteinmed.org to find out more. Transformative Research in Diabetic Nephropathy (TRIDENT) Summary: Patients with diabetes will have extra biopsy core collected at time of biopsy (the study team will facilitate collection of biopsy core). Patients will then return for semiannual study visits for 2-3 years for follow up. Specimens will be sent to the University of Pennsylvania for molecular analyses to identify novel mediators of progression of diabetic kidney disease. Principal investigator: Dr. Michael Ross Major eligibility criteria: Patients with Type 1 or Type 2 diabetes undergoing kidney biopsy Vertex VX19 NEN 801 Summary: This is a study of the prevalence of APOL1 alleles among individuals with proteinuric kidney disease Who Are of Recent African Ancestry or Geographic Origin. Participants will have one study visit during which a saliva and blood sample are taken to genotype for APOL1. Results will be sent to the principal investigator, who will coordinate release of results to participant and arrange for genetic counseling, if the patient desires. Principal investigator: Dr. Michael Ross Major eligibility criteria: Patients with focal segmental glomerulosclerosis or non-diabetic CKD (i.e., urine protein to creatinine ratio>0.1 and without obvious systemic cause of CKD such as diabetes and autoimmune disorder). Calciprotein Particles and Aortic Micro-calcification in Kidney Disease Summary: This study aims to study the relationship between blood calciprotein particle level and micro-calcification (calcification nodule 50 um) in aorta of people with kidney disease. Participants will undergo blood draw and a 18Fluorine-sodium fluoride positron emission tomography/computed tomography (18F-NaF PET/CT). No nephrotoxic intravenous contrast agent will be given. Principal investigator: Dr. Wei Chen Major criteria to enter the study: adults with kidney disease stage 3b-4. Please email sara.saini@einsteinmed.edu to find out more. Cellular Interactions in Vascular Calcification Summary: This study aims to study the interactions between endothelial cells and vascular smooth muscle cells in the pathogenesis of vascular calcification. We will collect blood samples from patients on hemodialysis. For controls, we will use blood samples from age- and sex- matched healthy volunteers. Principal investigator: Dr. Wei Chen Major criteria to enter the study: Adults on hemodialysis, but without diabetes. Please email sara.saini@einsteinmed.edu to find out more.
