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

RenaMed Biologics

Status and phase

Terminated

Phase 2

Conditions

Kidney Failure, Acute

Treatments

Device: Renal Assist Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00280072

RAD-003

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A clinical diagnosis of Acute Tubular Necrosis (ATN)
At least one non-renal organ failure

Exclusion criteria

A renal transplant at any time
Chronic renal failure occurring due to reasons other than Acute Tubular Necrosis (ATN)
Chronic
Chronic immunosuppressive therapy