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We are dedicated to advancing kidney care through cutting-edge clinical research. Our commitment to research drives our mission to improve patient outcomes and contribute to the broader medical community.
Study Name: A Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease Undergoing Dialysis.
Sponsor Name: CSL Behring LLC
Study Phase: Phase III
Status: Enrollment on-going.
Investigational Product: CSL-300 (monoclonal antibody against IL-6)
Primary Objective: To evaluate the efficacy of CSL300 on reducing the risk of CV events (composite endpoint of CV death and MI).
Primary Endpoint: Time to first occurrence of CV death or MI.
Principal Investigator: Dr. Jodumutt G. Bhat
Study Name: A Phase I/III Randomized, Double-Blind, Active Controlled Study to Evaluate the Efficacy and Safety of AZD3152 for Pre-Exposure Prophylaxis of COVID-19 in Participants with Conditions Causing Immune Impairment
Sponsor Name: AstraZeneca
Study Phase: Phase III
Status: Ongoing. Enrollment is closed.
Investigational Product: AZD3152 (a monoclonal Ab) 300 mg single IM dose (300 mg Placebo + 300 mg AZD3152)
AZD7442 (EVUSHELD) (a monoclonal Ab) 600 mg single IM dose (300 mg AZD1061 + 300 mg AZD8895)
Primary Objective: To evaluate the safety and efficacy of AZD3152 in adults and adolescents 12 years of age and older with immune impairment.
Principal Investigator: Dr. Jodumutt G. Bhat
Study Name: A Randomized Parallel-group, Placebo-controlled, Double-blind, Event-driven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients with End Stage Renal Disease Receiving Hemodialysis.
Sponsor Name: Merck, Sharp and Dohme Corp.
Study Phase: Phase II
Status: Ongoing. Enrollment is closed.
Investigational Product: MK-2060 (monoclonal antibody against Factor XI)
Primary Objective: The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an arteriovenous graft (AVG).
Primary Endpoint: Time to First AVG Thrombosis Event: From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 17 months.
Principal Investigator: Dr. Jodumutt G. Bhat
Study Name: Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation.
Sponsor: Novo Nordisk
Study Phase: Phase III
Status: Ongoing. Enrollment is closed.
Investigational Product: Ziltivekimab (human monoclonal Ab to IL-6) 15 mg/mL (1 mL) s.c. once monthly
Primary Objective: To demonstrate the superiority of Ziltivekimab in reducing the risk of MACE compared to placebo in patients with ASCVD, CKD and systemic inflammation.
Primary Endpoint: Time from randomization to first occurrence of MACE.
Principal Investigator: Dr. Jodumutt G. Bhat
Besides Pharmaceutical sponsored clinical trials, the Research Department also collaborates with New York University (NYU) and Weill Cornell Medicine (WCM) for completion of their projects.
Research Department also have a non-disclosure agreement with the well-known Contract Research Organization (CRO) (such as Covance, ICON, IQVIA, Frenova Renal Research, DaVita Clinical Research, Medpace, Biorasi) for prospective clinical trials focusing on CKD/ESRD patients.
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