Ongoing studies

We are dedicated to translating our research findings into real-world applications that benefit our patients and the community at large.

2024

ESRD HD CV OUTCOME STUDY (POSIBIL6ESKD)

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

COVID-19 PASSIVE IMMUNIZATION (SUPERNOVA) STUDY

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

2023

2022

FACTOR XI HEMODIALYSIS STUDY

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

EX6018-4758: ZEUS CV OUTCOME STUDY

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

2021