The addition of human renal tubule cell therapy to CRRT has been accomplished and demonstrates metabolic activity with systemic effects in patients with ARF and MOF. These initial clinical results are encouraging, so that a randomized, controlled Phase II clinical trial is underway to further assess the clinical safety and efficacy of this new therapeutic approach.

Different recombinant human erythropoietin products have been developed. Although they appear to have similar pharmacokinetics and function, these have not been directly compared. This randomized, double-blind, four-period crossover study compared the pharmacokinetics and pharmacodynamics of intravenous and subcutaneous epoetin alfa and epoetin beta in 18 normal male volunteers. As a control, three subjects received placebo treatment. After intravenous administration, the steady-state volume of distribution and beta-phase volume of distribution of epoetin beta were 7.7% and 16.9% larger than for epoetin alfa (p less than 0.05). The terminal elimination half-life after intravenous administration of epoetin beta was 20% longer than the terminal elimination half-life of epoetin alfa. After subcutaneous administration there was a delayed drug absorption with epoetin beta compared with epoetin alfa (p less than 0.05). There was a small but significantly greater absolute reticulocyte response after subcutaneous epoetin beta compared with subcutaneous epoetin alfa. The findings support differences in the pharmacokinetics and function of epoetin alfa and beta that are possibly caused by differences in their glycosylation.

Background: The poor outcomes in patients with acute kidney injury (AKI) and end-stage renal disease (ESRD) on chronic dialysis are due to immune dysregulation associated with these disorders. Evolving evidence suggests that the kidney, and specifically renal epithelial cells, plays an important role in the immunological response of leukocytes under disease states. Method: In this regard, the development of two therapeutic approaches utilizing renal epithelial cells and ‘smart’ immunomodulatory membranes has been tested in preclinical animal models and clinical trials. Results: These two approaches have been demonstrated in phase II human trials to improve the survival of intensive care unit patients with AKI and multiorgan failure. The use of a ‘smart’ immunomodulatory membrane is also being evaluated in a small exploratory clinical trial to assess its effects on immunoregulation in ESRD patients requiring chronic hemodialysis. Conclusions: The use of renal progenitor/stem cell therapy and/or cytopheretic membranes may result in effective treatments to alter the dysregulated immunological state of acute or chronic renal failure and improve the outcomes of these diseases.

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