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KT-301 for Chronic Kidney Disease Stage IV (CKD Trial)
CKD Trial Summary
This trial is testing a live biotherapeutic product, US-APR2020, for safety and effectiveness in treating patients with CKD Stage IV.
- End Stage Renal Disease (ESRD)
CKD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CKD Trial Design
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Who is running the clinical trial?
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- You have taken probiotic supplements in the last 3 months.You are currently taking medications that weaken your immune system for kidney diseases.You have HIV/AIDS.You are very thin based on your weight and height.You are taking certain blood-thinning medications, like warfarin or newer oral anti-coagulants approved by the FDA in the last 10 years.You are currently undergoing peritoneal dialysis.You have a recent kidney problem.You are between 18 and 80 years old.Your kidneys are not working well, and this has been going on for more than 6 months.Your blood creatinine level is higher than 2.0 mg/dL.You need to follow a low protein diet of 0.6-0.8 grams per kilogram of body weight each day, as advised.You have an infection that needs to be treated with oral antibiotics when you start the study or around that time.You had surgery to implant a prosthesis (like a joint replacement or heart valve) less than 2 years ago. If it's been more than 2 years, this criterion doesn't apply to you.You have had a biological tissue graft, prosthesis, or implant.
- Group 1: KT-301 (formerly US-APR2020)
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is US-APR2020 known to have negative side effects for patients?
"While Phase 2 trials have yielded some evidence of safety, there is yet to be data supporting efficacy. Therefore, the Power team has given US-APR2020 a score of 2."
Are there any remaining vacancies for this clinical trial?
"The trial, which was originally advertised on 6/24/2021, is currently looking for participants. According to the most recent update on clinicaltrials.gov (10/11/2022), the study is still recruiting."
How many people are allowed to enroll in this research project?
"In order to run this clinical trial, 630 patients that fit the inclusion criteria are required. The sponsor, Kibow Pharma, will be managing the study from various locations like 01-008 in Woodbridge, Virginia and 01-020 in Newnan, Georgia."
How many different areas are responsible for this clinical trial?
"Currently, there are 23 patients enrolled in this study taking place at 01-008 in Woodbridge, 01-020 in Newnan, 01-021 in Fort Pierce and 20 other locations."
Are test subjects of this experiment only those over 30 years old?
"According to the entry requirements for this study, any patient aged 18-80 can sign up. There are 43 medical trials currently underway for patients that are under 18 and 475 for those over 65 years old."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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