THE BIOARTIFICIAL KIDNEY

Clinical trials

Bioartificial kidney for acute renal failure
Clinical trials of the bioartificial kidney showed efficacy in treating acute renal failure (ARF).

Phase IIb human trials of the first generation bioartificial kidney were conducted from March 2004 through December 2005 at 12 medical centers in the United States under a corporate-sponsored (RenaMed Biologics, Inc., Lincoln, RI) Investigational New Drug application. Patient treated with the device showed improve chance of survival (by 50% over traditional therapy alone) and its use was associated with accelerated recovery of renal function (with reduced stay in ICU). The device was well tolerated and had the adverse event profile expected for critically ill patients with acute renal failure. Results were reported in The Journal of the American Society of Nephrology.

Recruitment for the study was suspended because of slow patient enrollment-- due to strict enrollment criteria, including severity of illness (test patients were in acute renal failure and multiorgan failure). No volunteers were or are needed for this study-- and corporate need to assess the program. An interim analysis was conducted by an independent data monitoring committee, after which a corporate decision was made to discontinue enrollment in this study and proceed to the design of a confirmatory Phase II study. Inquiries about that study should be directed to the RenaMed succssor company: Cytopherx, inc.

Unexpected but compelling results: Meanwhile, data from the trial gave rise to new, promising avenues of inquiry which has led our lab to develop other new treatments for kidney failure, particularly disorders of the inflammatory response related to kidney failure. The approach is also promising for treating other conditions caused, exacerbated and/or characterized by unwanted inflammation.

Towards a Wearable Bioartificial Kidney (WeBAK)

Promise for Chronic Renal Failure
The bioartificial kidney used in the acute renal failure (ARF) clinical trials further demonstrated promise for treating end stage renal disease (ESRD)-- by supplementing conventional small solute clearance (hemodialysis or hemofiltration) with the endocrine and metabolic function provided by living cells.

We are currently working to miniaturize the renal tubule component of the bioartficial kidney and combine it with sorbent dialysis (a technology for regenerating dialysate fluid) and our BRECS cell therapy system to create a wearable, continuous-acting, long term bioartificial kidney for treating Chronic Renal Failure

At least five years away
This development is in preclinical testing. No volunteers are needed at this time.

Background
Jump to background information about the bioartificial kidney.


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