Developed by Natarajan Ranganathan, PhD, the supplement consists of proprietary strains of probiotic organisms that feed preferentially on waste products such as urea, creatinine and uric acid that are not being eliminated by underperforming, diseased kidneys. As these become more concentrated in the blood, some leak into the gut, where the strains in the Renadyl supplement feed upon them, lower the concentration in the gut. Diffusion then drives increasing amounts of the waste products into the gut, lowering blood concentrations.
“The concept is when the kidney fails the toxins increase in the blood, and your blood flows all over your body, but the largest amount of blood flow is in your bowel,” Raganathan said. The bowel’s surface area is equivalent to that of a tennis court, he said, and the idea was to use that vast absorption capacity to help soak up these toxins. Raganathan’s first idea, which he started on more than a decade ago on an NIS grant, was to genetically modify probiotic organisms for this task but that approach ran into both technical and regulatory difficulties.
“We turned around and screened various naturally occurring microbes and found some that can use these toxins,” Raganathan said. “These are naturally occurring microbes and we found out that some of these microbes had a greater capacity to utilize the uremic toxins if you grow them under proprietary conditions, or what we call uremic conditions.”
The product features a hefty dose of 30 billion CFU of three proprietary strains of S. themophilus, L. acidophilus and B. longum. Kibow has multiple patents on the strains and its technology in the US, Canada, India and other countries.
At the moment, Kibow Biotech sells the product in the US via its online store, partly because the product needs to be refrigerated, Raganathan said. But it devotes most of its educational outreach to conferences dealing with kidney disease issues, as it did at the recent meeting the American Association of Diabetic Educators conference, which took place earlier in August in Philadelphia.
Big market potential
The rise in obesity rates in recent years and the attendant rise in kidney disease rates means there is huge potential market for a dietary supplement like Renadyl, Raganathan said.
“I think this has the same potential as fish oil,” he said. “I come from a country (India) with limited access to dialysis, and I have had relatives who have died from kidney failure. My thought is if I made this into a pharmaceutical, it would benefit people in rich countries and it would not be accessible to poor people. So I want to keep it as a dietary supplement and it would be a huge challenge anyway to turn a probiotic into a drug.”
A number of studies have been done on the product showing its effectiveness. But despite his belief in the product’s effectiveness, Ragnathan said he’s well aware of the fine line that separates acceptable dietary supplement language from illegal drug claims.
“We talk about ‘enteric toxin reduction technology,’ ” Raganathan said. “We cannot use the word ‘dialysis.’ We clearly state the product is not intended to treat disease. I can make a structure function claim, which is to support healthy kidney function.”