What Are Clinical Trials and Why Should You Care?
Article posted in: Gut Health, Kidney Health

If you’ve ever wondered, “what are clinical trials?” and “are they important?”- you’ve come to the right place. We are here to help answer any questions you may have. 

Have you taken a dietary supplement and seen this on the label?

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

FDA Disclaimer

You may have asked yourself, “If they have to display this label, how is this product even safe?” Well, dietary supplement companies have to put this labeling down when making any claims because the US FDA does not regulate most supplements. The US FDA regulates drug products, NOT dietary supplements.

What are they 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’re are often used to learn more about new treatments, if they are effective, and/or have side effects. (1) When a new product is being studied, it is often not known if it will be helpful, harmful, or any different from existing products/treatments. Before the US 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 begin. (1)

The 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 studies. (2) 

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?

Since a dietary supplement cannot be approved by the US FDA, the next best thing to ensure effectiveness is to carry out small scale clinical trials with the supplement. We always want our customers to feel 100% safe when taking Renadyl™, that’s why we take pride in our pharma-like validation. Renadyl™ has undergone three studies to ensure its safety and efficacy to help maintain healthy kidney function.  

1. A dose-escalation open-label studies on Chronic Kidney Disease (CKD– stages III and IV) at Thomas Jefferson University, Philadelphia, PA 
   1. 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.
2. A randomized, double-blind, placebo-control, cross over design clinical study in CKD V (Dialysis Patients) at Downstate Medical Center (State University of New York) and Kings County Hospital in Brooklyn.
   1. 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.
3. 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™.
   1. Decreases in serum levels of blood urea nitrogen, creatinine, and uric acid were seen. Read more here.

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! To read more about Renadyl™ and its completed clinical trials, click here.

The future of Renadyl™

We will continue to test and improve Renadyl™, the world’s only probiotic for maintaining healthy kidney function! We will also continue to educate those who are susceptible to impaired renal function or already have impaired renal function. Supporting and assisting our customers is a priority of ours and we take pride in always being there to provide whatever information they may need. 

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.

Interested in participating in clinical trials? 

If you find yourself being interested in learning more or participating in clinical trials, we have put together some resources to check out: 

1. National Kidney Foundation

The National Kidney Foundation has a great tool to help find a trial to participate in based on your specific needs. This short quiz takes under 60 seconds. 

2. The American Kidney Fund FAQs

The American Kidney Fund may have the answers to any questions you have regarding participating in clinical trials. They too have a quiz that helps you find which may be best for you. 

3. Center Watch List of Actively Recruiting Trials 

Center Watch has a large list of actively recruiting clinical trials. There is an option to enter your specific needs as it narrows the list down for you. 

Participating in these trials can be mentally and physically rewarding. On one hand, you may find a treatment that’s helping you. On the other hand, you are helping ensure that specific treatments are safe for others.

Remember to always consult with your healthcare practitioner to see if participating in clinical trials is right for you.

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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/