NEW YORK (Reuters Health) - The initial findings from the first human trial of a bioartificial kidney suggest that the device can safely improve a variety of metabolic disturbances in patients with acute renal failure (ARF). As such, a phase II clinical trial is already underway to better define the device's efficacy.

As the name implies, the bioartificial kidney consists of both living and synthetic materials. A synthetic hemofilter is attached to a bioreactor cartridge that contains billions of human proximal tubule cells.

As reported in the October issue of Kidney International, Dr. H. David Humes, from the University of Michigan in Ann Arbor, and colleagues assessed the outcomes of 10 patients with ARF and multiorgan failure. The predicted hospital mortality rate for the group averages above 85%.

The authors found that the bioartificial kidney could be successfully applied in a clinical setting. Treatment with the device was associated with a drop in levels of various proinflammatory cytokines.

All but one of the patients experienced an improvement in their acute physiologic scores. Moreover, six of the patients survived past 30 days, well above the expected survival rate for the group.

The results indicate that the bioartificial kidney is "well-tolerated by patients with ARF, and resulted in some improvement of the patients' clinical conditions," Dr. Humes said in a statement. "It's a small study but it was compelling enough for us and the FDA to go forward with a full phase II study."

At present, the bioartificial kidney is extracorporeal, but with further encouraging results, Dr. Humes said that the long-term goal would be to develop a fully implantable device.

Kidney Int 2004;66:1578-1588.

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