TIN816 / Novartis - LARVOL DELTA

Pharmacokinetics, Pharmacodynamics and Safety of TIN816 in Patients With Sepsis-Associated Acute Kidney Injury: Results From a Randomized Phase 2a Study (ERA 2025) - No abstract available

Clinical • P2a data • PK/PD data • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock

A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery. (clinicaltrials.gov) - P2 | N=98 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Phase 2b Trial to Assess the Safety and Efficacy of TIN816 in the Treatment of Adult Patients with Sepsis-Associated AKI (KIDNEY WEEK 2024) - P2 | "The primary objective of the study is to characterize the dose–response relationship of TIN816 on renal function measured by creatinine clearance (CrCl) in patients with SA-AKI. Secondary and exploratory objectives include the evaluation of safety and tolerability, all-cause mortality of TIN816 vs placebo, the effect of TIN816 vs placebo in reducing major adverse kidney events (MAKE), as well as the pharmacodynamic and pharmacokinetic characterization of TIN816.This dose-finding, Phase 2b study will provide evidence towards the safety and efficacy of TIN816 in the treatment of patients with SA-AKI (ClinicalTrials.gov: NCT05996835)."

Clinical • P2b data • Acute Kidney Injury • Chronic Kidney Disease • Hematological Disorders • Infectious Disease • Nephrology • Renal Disease • Septic Shock • Thrombocytopenia • ENTPD1

Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock

Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (SA-AKI) (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock

Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock

Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (SA-AKI) (clinicaltrials.gov) - P2 | N=320 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Phase classification: P2b ➔ P2

Phase classification • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock

Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Novartis Pharmaceuticals | Phase classification: P2a ➔ P2 | Trial completion date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2023 ➔ Mar 2024

Phase classification • Trial completion date • Trial primary completion date • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock

A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery. (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Oct 2024 ➔ Jul 2025 | Trial primary completion date: Oct 2024 ➔ Jul 2025

Surgery • Trial completion date • Trial primary completion date • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease

A Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of TIN816 in Patients at Risk for AKI Following Cardiac Surgery (KIDNEY WEEK 2023) - P2 | "Secondary objectives of the study include safety and tolerability of TIN816, the effect of TIN816 on incidence and severity of AKI, and the effect of TIN816 on acute kidney disease (AKD) as assessed by major adverse kidney effects on day 30 and day 90 post-surgery (MAKE30 and MAKE90). The study is currently enrolling and started in March 2023, with completion expected in October 2024."

Clinical • Surgery • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease • ENTPD1

Phase 2b Study to Investigate the Safety and Efficacy of TIN816 in Sepsis-associated Acute Kidney Injury (SA-AKI) (clinicaltrials.gov) - P2b | N=320 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P2b trial • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock • CST3

A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery. (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Surgery • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease

Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury (clinicaltrials.gov) - P2a | N=20 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock

A multi-center study to evaluate the safety, tolerability and efficacy of TIN816 in patients at risk for acute kidney injury following a cardiac surgery. (clinicaltrialsregister.eu) - P2 | N=120 | Ongoing | Sponsor: Novartis Pharma AG

New P2 trial • Surgery • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease

A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery. (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2024 ➔ Oct 2024 | Trial primary completion date: May 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease

A multicenter study to evaluate pharmacokinetics, safety and tolerability of TIN816 in patients with sepsis-associated acute kidney injury Estudio multicéntrico en el que se evalúan la farmacocinética, la seguridad y la tolerabilidad de TIN816 en pacientes con lesión renal aguda asociada a sepsis (clinicaltrialsregister.eu) - P2 | N=20 | Ongoing | Sponsor: Novartis Farmacéutica, S.A.`Novartis Pharma AG

New P2 trial • Acute Kidney Injury • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease • Septic Shock

A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery. (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P2 trial • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease

Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury (clinicaltrials.gov) - P2a | N=20 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P2a trial • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock