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Renadyl™ & Clinical Trials

What does it mean when we say that Renadyl™ is “clinically proven”?

Renadyl is a natural dietary supplement, and dietary supplement companies have to include disclaimers like this when making any claims because the US FDA, which regulates drug products, does not regulate most supplements.

Since dietary supplements cannot be approved by the FDA, the next best way to demonstrate and study their benefits is to carry out small scale clinical trials.

Have you seen this FDA disclaimer on the Renadyl site?

“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

What are clinical trials and why are they important?

Clinical trials are research studies that are performed on people and are aimed at the safety and efficacy of medical, surgical, or behavioral interference. They are often used to learn more about new products or treatments, and if they are effective or have side effects1.

When a new product is being studied, it is often not known if it will be helpful, harmful, or in any way different from existing products/treatments. Before the FDA approves a clinical trial to move forward, scientists test on animals, typically mice, to gauge the toxicity of the product. Once this is proven, human clinical trials may begin1.

Human studies begin by gauging the safety of the product in healthy human beings or healthy volunteers. Once this is established, the trials are carried out in the affected population. The safety and efficacy are measured by the different outcomes in patients participating in the studies2.

Thus taking part in clinical trials is a way for companies to ensure the safety and efficacy of products that are tested on human beings.

Has Renadyl had any clinical trials?

Renadyl improved kidney health and kidney function in multiple studies

Based on the results of the clinical trials and our three biennial customer surveys, we were able to come to the conclusion that Renadyl may help patients maintain healthy kidney function.*

Many patients using Renadyl for three months or more* saw their eGFR (Glomerular Filtration Rate) stabilize. Some even saw an increase in their eGFR!

We always want our customers to feel 100% safe when taking Renadyl, that’s why we take pride in our pharma-like validation. To read more about Renadyl and its completed clinical trials, click here.

A dose-escalation open-label studies on Chronic Kidney Disease (CKD– stages III and IV) at Thomas Jefferson University, Philadelphia, PA.

  • All patients with impaired renal function in this study received increasing dosages over a period of 6 months, with the maximum dosage of Renadyl for 2 months. A decline in uremic toxins, such as BUN and creatinine, was observed in patients. To read more about this study, click here.

A randomized, double-blind, placebo-controlled, crossover design clinical study in CKD V (dialysis patients) at Downstate Medical Center (State University of New York) and Kings County Hospital in Brooklyn.

  • In this study, all patients with impaired renal function took Renadyl or a placebo and were observed for six months. The evidence suggests that CRP and inflammatory levels were minimized over the course of 6 months. To read more about this study, click here.

A 6-month prospective, randomized, double-blind, placebo-controlled crossover trial at 5 different sites in the United States, Canada, Nigeria, and Argentina for its probiotic formulation, Renadyl.

What’s next for Renadyl?

We will continue to test and improve Renadyl in the future because supporting and assisting our customers is a priority of ours, and we take pride in always being there to provide accurate, up-to-date information.

Although Renadyl has performed several studies to ensure its safety, always remember to consult with your healthcare practitioner to see if Renadyl is right for you.

Sources

  1. What Are Clinical Trials and Studies? (n.d.). Retrieved June 16, 2020, from https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies 
  2. Learn About Clinical Studies. (n.d.). Retrieved June 16, 2020, from https://clinicaltrials.gov/ct2/about-studies/learn 
  3. Observational Study of Kibow Biotics in Chronic Kidney Failure Patients – Full-Text View. (n.d.). Retrieved June 16, 2020, from https://www.clinicaltrials.gov/ct2/show/NCT01450657?term=Kibow+Biotech 
  4. Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis – Full-Text View. (n.d.). Retrieved June 16, 2020, from https://www.clinicaltrials.gov/ct2/show/NCT01450709?term=Kibow+Biotech 
  5. Renadyl™ – Kidney Repair Probiotics: USA. (2019, August 23). Retrieved June 16, 2020, from https://kibowbiotech.com/clinical-trials/ 
  6. How can I find a clinical trial? (2020, April 08). Retrieved June 18, 2020, from https://www.kidney.org/atoz/content/how-can-i-find-clinical-trial 
  7. Clinical trials. (n.d.). Retrieved June 18, 2020, from https://www.kidneyfund.org/kidney-disease/clinical-trials/
  8. Kidney Disease Clinical Trials. (n.d.). Retrieved June 18, 2020, from https://www.centerwatch.com/clinical-trials/listings/condition/226/kidney-disease/