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Phase 3 Data

For more information, please contact us.

For more information, please contact us.

Study ATB-203

The Phase 3 trial, also known as the REAKT trial (Reltecimod Efficacy for Acute Kidney Injury Trial), is designed as a single pivotal study to assess the efficacy and safety of Reltecimod versus placebo in patients with SA-AKI.  The study is planned to recruit 120 patients, utilizing a 1:1 randomization schema, from approximately 80 investigative sites in the US, France, Belgium and the Netherlands.  It will be evaluating the clinical composite endpoint:

Composite of (Day 28):

– Alive
– Free of dialysis
– <37% irreversible loss of eGFR

Key secondary endpoints:

  • Safety of Reltecimod
  • Freedom from Durable Loss of eGFR
  • AKI-Free Days
  • Time to Primary Endpoint
  • Critical Care and Hospital Stay Parameters
  • Survival Status

For more information, please go tohttps://www.clinicaltrials.gov/ct2/show/NCT03403751?term=atox&rank=2