End stage renal disease (ESRD) is a devastating disease with a very high cost of treatment, especially for poor patients worldwide. Our R&D goal is to progressively develop a low-cost, non-invasive gut-based treatment for efficient removal of uremic solutes in renal failure patients. We plan to develop a therapeutic oral formulation in a stepwise methodology beginning with generation I to its ultimate optimized product generation IV. This is based on a formulation of a mixture of modified sorbents plus a genetically engineered bacterium which, in the gut, would adsorb and eliminate various uremic solutes through the bowel route. Our phase I proposal is specifically directed to develop the generation I formulation consisting of zeolite based sorbent material will be replaced by a genetically engineered E. coli DH5 cells which is expected to demonstrate better urea removal capabilities. These Generation I and Generation II formulations will be investigated for their in vitro adsorption capabilities for urea, creatinine and uric acid removal. These phase I R&D investigations are expected to furnish data necessary to accelerate the development of the generation III and subsequently the optimized generation IV formulation for our phase II studies.
The fully developed product will have immense applications towards treatment of uremic patients from predialysis to ESRD and possibly substitute the need for dialysis, especially in developing and under- developed countries. It is equally feasible that our oral formulation may also have applications as a adjunct therapy for dialysis.
| Ranganathan, Natarajan; Patel, Beena G; Ranganathan, Pari et al. (2006) In vitro and in vivo assessment of intraintestinal bacteriotherapy in chronic kidney disease. ASAIO J 52:70-9 |
| Ranganathan, Natarajan; Patel, Beena; Ranganathan, Pari et al. (2005) Probiotic amelioration of azotemia in 5/6th nephrectomized Sprague-Dawley rats. ScientificWorldJournal 5:652-60 |
