NYU Langone’s Division of Nephrology is currently recruiting enrollees for a wide range of clinical trials.

Chronic Kidney Disease Trials

David M. Charytan, MD, is leading the following chronic kidney disease trials:

• A Phase III, Randomized, Double-blind, Active-controlled Study to Assess the Efficacy, Safety, and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure
• A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
• Safety and Efficacy of Empagliflozin in Hemodialysis (SEED)
• Intradialytic Myocardial Study Stunning in Maintenance Hemodialysis Patients: A Multi-Center Observational Cohort Study
• AMPLITUDE Clinical Research Trial: Efficacy and Safety Of VX-147 in APOL1-Mediated Proteinuric Kidney Disease
• Deep Learning on ECGs to Improve Outcomes in Patients on Dialysis
• Salt-Substitute in Hemodialysis-Dependent End-Stage Kidney Disease (SHED)

Lama Nazzal, MD, is leading the following studies:

• Serum Oxalate in ESKD: Role of Gut Microbiota in Oxalate Homeostasis in ESKD Patients
• A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index (BMI) ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease: (TRIUMPH-OUTCOMES)
• Effect of Canagliflozin on Uremic Solute Production and Gut Microbiome Composition (Dr. Jerome Lowenstein, Dr. Lama Nazzal)

Hyperoxaluria Trials

Lama Nazzal, MD, is leading the following hyperoxaluria trials:

• Gut Kidney Axis in Enteric Hyperoxaluria
• Enteric Hyperoxaluria Patient Registry NYULH Site: An Observational Cohort Study
• Descriptive Analysis of Gut Microbiome Alterations in Hyperoxaluric Patients

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.

We are also interested in treating rare, genetic causes of kidney stones. We are participating in trials of nedosiran, a molecule which is a small interfering RNA that interferes with the activity of lactic dehydrogenase (LDH-A). This molecule is responsible for oxalate synthesis in the liver. Its inhibition leads to a reduction in oxalate production in patients with primary hyperoxaluria, three types of hepatic mutations associated with hyperoxaluria, which leads to kidney stones and decreased kidney failure. Nedosiran (brand name Rivfloza) is now approved for the treatment of PH1.

Nedosiran in Primary Hyperoxaluria

David S. Goldfarb, MD, is evaluating the use of nedosiran in several primary hyperoxaluria trials:

• A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of DCR-PHXC in Patients with Primary Hyperoxaluria Type 1 or 2 and Severe Renal Impairment, with or without Dialysis
• An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients with Primary Hyperoxaluria
• A Natural History Study of Patients with Genetically Confirmed Primary Hyperoxaluria Type 3 with a History of Stone Events

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)
• Consortium for Hereditary Causes of Nephrolithiasis and Renal Failure: Cystinuria (6401)
• 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.

Nicole M. Ali, MD, is leading the following trials:

• A Dose Escalation and Proof-of-Concept Study of REGN5459 or REGN5458 (BCMAxCD3 Bispecific Antibodies) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen
• A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 with REGN5459 or REGN5458 (BCMA × CD3 Bispecific Antibodies) Who Receive a Kidney Transplant

Michal L. Melamed, MD, is leading the following trial:

• Interventions for Promoting Kidney Transplant Equity (INSPIRE)

Irfana Soomro, MD, is investigating the following:

• A Multi-Cohort, Randomized, Phase 2, Open-Label Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of BIVV020 for Prevention and Treatment of Antibody-Mediated Rejection in Adult Kidney Transplant Recipients
• A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients

Vasishta Tatapud, MD, is leading the following trials:

• An Open Label, Phase II Study to Investigate DSA Rebound in Patients with a Positive Crossmatch, Made Transplantable with Imlifidase
• APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)

Bonnie E. Lonze, MD, PhD, is leading the following trials:

• A Pilot Study of Post-Transplant Eplet Mismatch Analysis for Kidney Transplant Recipients to Inform Strategic Immunosuppression Reduction
• An Open-Label, Controlled, Randomized Phase 3 Trial Evaluating 12-Month Kidney Function in Highly Sensitized DDKT Patients with Positive Crossmatch, Comparing Desensitization Using Imlifidase with SOC

Sapna Mehta, MD, is investigating the following:

• Single-Center Pilot Study of Living Donor Kidney Transplant from HIV-Positive Donor to HIV-Positive Recipient

Glomerular Disease Trials

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.

Dr. Zhdanova is also leading the following trials:

• A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients
• A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy

Other Kidney Trials

Daniel Cukor, PhD, is leading the following trial:

• A Pilot Trial of Strategies to Reduce Fatigue for People with Chronic Kidney Disease

Morgan Grams, MD, PhD, is leading:

• Integrated Multi-omics Approaches to Precision Medicine in Kidney Disease (iMAP-Kidney)

Jennifer S. Scherer, MD, is leading these trials:

• Unmet Social Needs and Disease Burden Among Adults with Kidney Failure: An Observational Study
• Integrated Supportive Care with Nephrology Care in Patients with Advanced CKD

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 Lois.Katz@NYULangone.org.

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.

The Kidney CARES Program is led by Jennifer S. Scherer, MD, who is board-certified in both palliative care and nephrology. To learn more about the program, contact Dr. Scherer at Jennifer.Scherer@NYULangone.org.