Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511407
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2007-08-02
Brief Title:
Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
Sponsor:
RenaMed Biologics
Organization:
RenaMed Biologics
Study Overview
Official Title:
A Multi-Center Randomized Phase II Study To Assess Safety and Efficacy With the Renal Assist Device RAD In Patients With Acute Renal Failure
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although conventional hemodialysis removes waste products and corrects fluid imbalance it does not replace critical absorptive metabolic endocrine and immunologic functions performed by healthy renal tubule cells This trial involving patients with acute renal failure evaluates the efficacy and safety of an extracorporeal renal assist device RAD containing human renal tubule cells connected to a conventional hemodialysis circuit It is hypothesized that short-term 72-h use of this cell therapeutic device will improve survival of ARF patients compared to patients receiving only conventional continuous renal replacement therapy
Detailed 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 andor SIRs and facilitate the natural recovery of a patients 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 patients own kidneys to resume normal functions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None