Clinical Trial: Study to Evaluate the Safety and Efficacy of the Renal Assist Device in Patients With Acute Renal Failure

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multi-Center, Randomized, Controlled, Double-Blind, Phase II Study To Assess Safety and Efficacy With the Renal Assist Device (RAD) in Patients With Acute Renal Failure

Brief Summary:

  • The purpose of this study is to evaluate the safety and efficacy of the RAD to determine whether the RAD is effective in reducing mortality in patients with Acute Renal Failure due to Acute Tubule Necrosis and to evaluate the safety of the RAD
  • If the RAD works normally when used for as long as 72 hours
  • If the RAD will provide added benefits to normal CVVH therapy for patients with Acute Renal Failure

Detailed Summary: Acute Renal Failure (ARF)is a severe inflammatory disease state often accompanied by Multi-Organ Failure (MOF) and Systemic Inflammatory Response Syndrome (SIRS). ARF is precipitated by many factors and is most often linked to the loss of kidney tubule cell function. Patients with ARF are treated in the intensive care units of hospitals and recovery of renal function is vitally important to their survival. Current therapy for ARF involves conventional kidney support with continuous renal replacement therapies (CRRT). Despite advances in treating patients with CRRT, ARF has an extremely high mortality rate (55-70%) and requires extensive hospital stays, predominantly in the ICU. The RAD is designed to both treat ARF with MOF and/or SIRs and facilitate the natural recovery of a patient's own kidney function. The RAD is intended for use for short periods of time in conventional extracorporeal therapeutic systems that are already available in the hospital. The RAD therapy operates outside the body, and is designed to mimic the structure and function of the natural kidney. In this manner it is intended to replace the missing metabolic, endocrine, and immunologic functions of the kidney and allow time for the patient's own kidneys to resume normal functions.
Sponsor: RenaMed Biologics

Current Primary Outcome: To evaluate all cause mortality at Day 28

Original Primary Outcome: Same as current

Current Secondary Outcome: To assess the effect of RAD treatment in measures of patient's safety and clinical outcome

Original Secondary Outcome: Same as current

Information By: RenaMed Biologics

Dates:
Date Received: January 18, 2006
Date Started: January 2006
Date Completion:
Last Updated: November 29, 2012
Last Verified: November 2012