On-Going Clinical Studies Our Friendly Study Coordinators Lisandra Ninonuevo William Paredes Cynthia Rivera Khyra Cunningham Summary of Study Key Points Firstx trial: Adults with primary FSGS and immunosuppression-naïve Vascular Calcification in CKD: CKD patients getting AVF/AVG surgery TRIDENT study: Patients with diabetes undergoing kidney biopsy Physical function in CKD: Ambulatory patients with CKD stage 4 or 5 ASCEND-ND: CKD 3-5 receiving an ESA or you are considering starting an ESA Peer Mentorship in HD: non-adherent or extremely adherent HD patients at Davita units Peer Mentorship for Patients on Hemodialysis Study summary: peer mentorship has been used effectively to enhance self-motivation and self-management behaviors in patients with chronic disease Peer mentorship improves patient adherence and quality of life scores in a recent study of patients on dialysis. Peer mentorship is effective in reducing anxiety, increasing perception of social support and self-motivation through modeling and empathic listening, and is well suited to a dialysis population with a fixed schedule. This study is testing the effects of peer mentorship on the rate of hospitalizations in patients on hemodialysis. Principal investigator: Dr. Ladan Golestaneh and Dr. Michal Melamed Major criteria to enter the study: Both mentors and mentees are adult patients on hemodialysis. Mentors should 1) have no hospitalization in the previous 6 months, 2) adhere to dialysis treatment, 3) have arteriovenous access, and 4) on dialysis for more than 1 year. Mentee should 1) have one or more hospitalization or ED visits in the previous month or 2) missed treatment or 2 shortened dialysis treatment in the last month or 3) have dialysis catheter. Please email email@example.com to find out more. Improving Physical Function in Kidney Disease Study summary: It is not uncommon for people with kidney disease to get tired easily, lose muscle strength, and to have difficulty with physical activities. This is a study to learn more about why these problems develop and how we can prevent them. Principal investigator: Dr. Matthew Abramowitz Major criteria to enter the study: adults with stage 4 or 5 chronic kidney disease (kidney function approximately less than 30%), but not yet started on dialysis, who are able to walk (use of a walking aide is permitted). Please email firstname.lastname@example.org to find out more. Can We Predict the Future: Calcium Deposits in the Blood Vessels? Study summary: Patients with chronic kidney disease may have calcium deposits in their blood vessels. Calcium deposits in the blood vessels, also called vascular calcification, may lead to heart attack, heart failure and eventually death. The purpose of this study is to examine the relationship between a new blood calcification test and vascular calcification in people with chronic kidney disease. If the new blood calcification test can predict the development of vascular calcification, it can be used to prevent and guide future treatment for vascular calcification. Principal investigator: Dr. Wei Chen Major criteria to enter the study: adults with estimated glomerular filtration rate <25 ml/min/1.73m2 (kidney function approximately less than 25%), who have a scheduled vascular access surgery (arteriovenous fistula or graft) at Montefiore Medical Center. Please email email@example.com to find out more. Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) Study summary: FSGS is a progressive disease that causes the kidneys to scar, to leak protein into the urine and may lead to kidney failure. This study is being done to see whether a new study drug, called CXA-10, can reduce the amount of protein in the urine and maintain stable kidney function in subjects with FSGS. The study will look at whether different doses of CXA-10 have different effects on urine protein as well as other positive and negative effects of CXA-10. CXA-10 is a substance that is naturally produced and normally found in the body in low levels. Based on earlier studies, it is believed that CXA-10 works by reducing inflammation in the body. Inflammation is one of the processes involved in FSGS. Because of CXA-10’s possible ability to reduce inflammation, researchers are hoping CXA-10 may be able to reduce kidney damage and urine protein loss in subjects with FSGS. Principal investigator: Dr. Tanya Johns Major criteria to enter the study: adults with a diagnosis of primary FSGS and estimated glomerular filtration rate of 45 ml/min/1.73m2 or more (kidney function approximately 45% or more). Please email firstname.lastname@example.org to find out more. Transformative Research In DiabEtic NephropaThy (TRIDENT) Study summary: About 2 in 5 people who are undergoing a kidney biopsy have diabetes. Diabetes is a common finding in people with kidney disease, but little is known about the specific ways in which diabetes affects kidney function. The purpose of this study is to gather a group of patients with diabetes who undergo a kidney biopsy to create a source of information with genetic, blood, and urine samples available, by which researchers can study how diabetes affects kidney function. Principal investigator: Dr. Michael Ross Major criteria to enter the study: People with diabetes and planned medically indicated kidney biopsy (prescribed by a practicing nephrologist). People on dialysis will not be eligible. Please email email@example.com to find out more. Anemia Treatment in Kidney Disease Study summary: We are conducting several trials comparing standard treatment of anemia with a new investigational oral medication. Principal investigator: Dr. Matthew Abramowitz Major criteria to enter the study: adults with stage 3, 4, or 5 chronic kidney disease (kidney function less than 60%) who have been diagnosed with anemia. People who have never been treated for anemia, as well as those already receiving treatment, may be eligible. Please email firstname.lastname@example.org to find out more.