Division of Nephrology Research
Faculty members in NYU Langone’s Division of Nephrology conduct research aimed at improving treatments for people with kidney conditions.
Our team’s current areas of interest include cardiovascular disease in the setting of kidney disease, the progression of chronic kidney disease, kidney stones, hyperoxaluria, and kidney transplant. In addition, our faculty have created and maintain two rare-disease registries for Dent disease and for cystinuria.
The following clinical trials are currently recruiting enrollees.
Chronic Kidney Disease Trials
COVID-19 Vaccine Hesitancy in End-Stage Kidney Disease
Lama Nazzal, MD, is characterizing the determinants of COVID-19 vaccine hesitancy in a diverse end-stage kidney disease (ESKD) population. The purpose is to perform multidisciplinary and tailored interventions to increase vaccine acceptance in ESKD patients. See full trial information.
FLOW: Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects with Type 2 Diabetes and Chronic Kidney Disease
Lifestyle Management of Chronic Kidney Disease in Obese Diabetic Patients
Use of Patiromer to Transition Chronic Kidney Disease Patients with Hyperkalemia to a Plant-Rich Diet
David S. Goldfarb, MD, is enrolling people with chronic kidney disease and high concentrations of potassium in their blood, a condition called hyperkalemia, in this study. The purpose of the study is to see whether the drug patiromer can keep blood potassium levels in the normal range in people with chronic kidney disease and mild hyperkalemia who are transitioned to a plant-rich diet that includes high potassium foods. See full trial information.
A Phase IV, Double-Blind, Placebo-Controlled, Multi-Center Trial To Study the Effects Of Evolocumab in Stage IV–V Chronic Kidney Disease: The Cardiovascular and Lipid-Lowering Effects of Evolocumab in Advanced Chronic Kidney Disease Trial
David M. Charytan, MD, is evaluating the effect of evolocumab (Repatha®) in patients with chronic kidney disease. The purpose of this study is to evaluate the effect of evolocumab (Repatha®), a Food and Drug Administration (FDA)–approved biological drug that has been shown to reduce LDL cholesterol (bad cholesterol). Early data show that the benefits of evolocumab may be increased as kidney function declines. This trial is therefore designed to provide additional evidence regarding the safety and cholesterol-lowering effects of evolocumab compared with placebo, a pill that has no therapeutic effect, in advanced CKD patients. See full trial information.
A Phase II Placebo-Controlled Double-Blind Multicenter Study to Evaluate the Efficacy Safety and Tolerability of DCR-PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria
Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients
Lama Nazzal, MD, is characterizing the microbiome in four groups of subjects—(1) people with primary hyperoxaluria type I; (2) people with idiopathic calcium oxalate stones; (3) people with enteric hyperoxaluria; and (4) healthy participants—by comparing the number of species and diversity of the microbial populations and pathways for oxalate metabolism by paralleling the gene expression of enzymes involved in oxalate degradation by gut bacteria. See full trial information.
Kidney Stone Trials
Our faculty investigate treatments for kidney stones and, in collaboration with the Rare Diseases Clinical Research Network, collect tissue samples for a kidney stone biobank.
Nedosiran in Primary Hyperoxaluria
David S. Goldfarb, MD, is evaluating the use of nedosiran in multiple primary hyperoxaluria trials:
A Phase 1 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of DCR-PHXC in Patients with Primary Hyperoxaluria Type 3
A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients with Primary Hyperoxaluria
Effect of Hydroxycitrate on Urine Chemistry
David S. Goldfarb, MD, is studying hydroxycitrate (HCA) as a potent inhibitor of calcium oxalate crystal growth that can lead to the dissolution of the crystals. The purpose of this research study is to investigate the effect of HCA supplements on HCA urinary excretion and on urine chemistries in kidney stone formers and subjects without kidney stones. See full trial information.
Rare Kidney Stone Consortium Trials
David S. Goldfarb, MD, together with researchers from the Mayo Clinic and University of Iceland, is working with the Rare Kidney Stone Consortium (RKSC) to establish robust disease registries. NYU Langone is the lead site for the Cystinuria Registry and the Dent Disease Registry.
The RKSC program includes the following studies:
Biobank Protocol (6404)
Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients with Cystinuria (RKSC 6413 and RKSC6421)
Prospective Research Rare Kidney Stones (ProRKS) (RKSC 6417)
Kidney Transplant Trials
As members of the NYU Langone Transplant Institute, our faculty conduct trials in kidney transplant.
A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients
Irfana Soomro, MD, is investigating the effectiveness and safety of treatment with clazakizumab compared with a placebo in kidney transplant recipients with chronic active antibody-mediated rejection. See full trial information.
Single-Center Pilot Study of Living Donor Kidney Transplant from HIV-Positive Donor to HIV-Positive Recipient
Glomerular Disease Trials
Nephrotic Syndrome Study Network (NEPTUNE)
Olga Zhdanova, MD, is studying nephrotic syndrome as part of the Nephrotic Syndrome Study Network (NEPTUNE). The purpose of this study is to gather long-term observational data to help understand the biology behind nephrotic syndrome. This study includes the following conditions: minimal change disease, membranous nephropathy, and focal segmental glomerulosclerosis. See full trial information.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy
A Randomized Treatment, Open-Label, Dose-Blinded, Parallel-Group, Three-Arm, Proof-of-Concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared with Rituximab in the Treatment of Subjects with Idiopathic Membranous Nephropathy
A Phase II, 12-Week, Adaptive, Open-Label, Sequential Cohort Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of PF-06730512 Following Multiple Doses in Adult Subjects with Focal Segmental Glomerulosclerosis
Other Kidney Trials
A Randomized-Controlled Trial of Integrated Palliative and Nephrology Care versus Usual Nephrology Care
RADAR: Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes
Nephrology Clinical Trials Closed to Recruitment
The following trials are active but are no longer recruiting enrollees.
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients with Hyperoxaluria and Kidney Stones
Lama Nazzal, MD, is evaluating the efficacy of ALLN 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. See full trial information.
The NGAL Test as an Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population
David M. Charytan, MD, MSc, is investigating whether the neutrophil gelatinase–associated lipocalin, or NGAL, test can be used as a predictor for acute kidney injury in patients who have been admitted to the intensive care unit. See full trial information.
Efficacy and Safety of Selonsertib in Participants with Moderate to Advanced Diabetic Kidney Disease (MOSAIC)
Other Division Research
Our faculty expand the field of knowledge in nephrology through these additional research studies.
ACCORDION: The ACCORD Follow-On Study
ACCORDION is a prospective, observational follow-up study of at least 8,000 participants who were treated and followed in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Treatment in ACCORD ended in 2009, and ACCORDION is designed to further elucidate the long-term effects of the ACCORD treatment strategies and provide additional data on the relationships among various cardiovascular and diabetic risk factors. ACCORDION is sponsored by the National Heart, Lung, and Blood Institute.
ACCORDION has provided the scientific community with a large, rich, evolving database that may be examined to address many questions. For more information about the study, contact Lois A. Katz, MD, at email@example.com.
CKDOPPS: Chronic Kidney Disease Outcomes and Practice Patterns Study
This study measures the effect of treatment options on chronic kidney disease (CKD) patients’ survival, quality of life, dialysis need, and costs. As this study is being conducted from clinics across the country, a goal is to represent a varied sample of CKD clinics. This research ultimately aims to contribute to effective treatment practices for CKD patients, who face high clinical risk and healthcare costs that come with the disease.
Kidney CARES Program
NYU Langone’s Kidney CARES Program provides palliative care for people with end-stage kidney disease and provides valuable and novel data that describe the clinical impact of integrated kidney and palliative clinical care.
For more information about Division of Nephrology research, contact Sobaata Chaudhry, clinical research coordinator, at 646-501-8453 or firstname.lastname@example.org or Frank Modersitzki, MPH, research coordinator, at 212-686-7500, extension 6379, or email@example.com.