Abstract: FR-PO339
Kibow Multisite Hope Study-CKD IV Randomized Clinical Trial Protocol: A Unique Double-Blind Placebo-Controlled Cross-Over Design Using Renadyl™ with Standard-of-Care Therapy (n=500-600, 20-25 sites in the United States)
Session Information
- CKD: Clinical, Outcomes, Trials - II
November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Ranganathan, Natarajan, Kibow Biotech, Inc., Newtown Square, Pennsylvania, United States
- Vyas, Usha N., Kibow Biotech, Inc., Newtown Square, Pennsylvania, United States
- Ranganathan, Pari, Kibow Biotech, Inc., Newtown Square, Pennsylvania, United States
- Irvin, Anthony, Kibow Biotech, Inc., Newtown Square, Pennsylvania, United States
- Weinberg, Alan D., Mount Sinai, Hackensack, New Jersey, United States
Background
CKD patients experience poor quality of life due to high levels of uremic toxins in the blood. Treatment option for CKD patients are restricted diet and medications for primary comorbidities like hypertension and diabetes. Outcomes like fatigue pain and anxiety though major concerns and critically important to patients and clinicians may not be reported in clinical trials (Kid Int 2019; 95:1280-1283). The Standardized Outcomes in Nephrology (SONG) initiative 2014 established core outcome sets for nephrology trials (https://songinitiative.org/). An alternative regime to address some of these issues would benefit all stages of CKD patients. Renadyl™, a Pro/Prebiotic dietary supplement is proven to reduce several uremic toxins in 3 pilot clinical trials with no reports of adverse outcomes. We propose to carry out large scale RCT to validate it as a Live Bio-Therapeutic (LBT) drug with US FDA approval.
Methods
One-year RCT cross over design in an outpatient setting. Renadyl™ will be orally given at 90 B CFU/day.
Results
Measured end points: 1: eGFR, Quality of Life (QOL). 2: Uremic metabolite panel, CBC, liver function test 3: Biomarkers including KIM-1, NGAL, TMAO, IL-6 and CRP.
Conclusion
This is the first-ever RCT proposed using Renadyl™ as a Live Bio-Therapeutic (LBT) drug for CKD IV patients. Being noninvasive the intervention avoids any possible infection. As a rare unconventional crossover design, patients will be their own control for prudent data analysis. Secondly, every patient gets the interventional product, thus accelerating better patient recruitment. Significance of p-value alone does not help in the decision of the application of results to clinical care and its policy (Kid Int. 2019; 95:28-30). P ＜ 0.05 and P ＞ 0.05 can affect interpretation and lead to bias. The study design, quality of measurements, and the logical basis of assumptions are also important. (Kor J Pain 2017; 30(4): 241-242). Addition of Renadyl™ with standard care of therapy may possess excellent potential towards CKD applications worldwide.
Seriously interested clinical PI’s please contact: rangan@kibowbiotech.com
Funding
- Commercial Support – Kibow Biotech Inc.