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RGLS8429 for Polycystic Kidney Disease
Study Summary
This trial is testing a new drug to treat ADPKD. The drug is being tested for safety and tolerability and its effects on biomarkers and kidney function.
- Polycystic Kidney Disease
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have taken tolvaptan within the 28 days before the study starts.You have had problems with drinking too much alcohol or using drugs in the past 2 years.You have only one kidney or have had a kidney transplant.It seems like there might be a typo or incomplete information in your request. If you can provide more details or clarify, I'd be happy to help rewrite the criterion for you.People with a specific genetic kidney disease, aged 18 to 70.You have a certain classification of ADPKD based on an MRI scan taken during screening or within the past 5 years.Your kidney function, measured by eGFR, needs to be between 30 and 90 mL/min/1.73 m2.Your body mass index (BMI) is between 18 and 35.
- Group 1: RGLS8429
- 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
What is the current number of participants in this experiment?
"In order to conduct this clinical trial, 36 eligible patients are needed. These people can be recruited from two medical institutions: Boise Kidney and Hypertension, PLLC in Nampa, Idaho or Academic Medical Research Institute in Los Angeles, California."
May I join the experiment as a research subject?
"This clinical trial is looking to recruit 36 individuals who suffer from autosomal dominant polycystic kidney disease and are between the age of 18-70. The minimum requirements for applicants include: being male or female, possessing a BMI ranging from 18-35 kg/m2, having an eGFR score within 30-90 mL/min/1.73 m2 and falling into Mayo Imaging Classification 1C, 1D or 1E (based on MRI results obtained either during screening or in the last 5 years). Furthermore, participants must comprehend what is explained in their ICF document and agree to adhere to it vigilantly."
How many locations are undertaking this investigation?
"Participants are being recruited at a total of 15 sites, including Boise Kidney and Hypertension PLLC in Nampa, Idaho; Academic Medical Research Institute in Los Angeles, California; St. Clair Nephrology Research in Roseville, Michigan; plus 9 other locations."
Has the U.S. Food and Drug Administration granted authorization for RGLS8429?
"Despite limited data regarding efficacy and safety, RGLS8429 was rated a 1 on our team's scale at Power. This is due to it being in the initial Phase 1 trial of testing."
Does this experiment have any open enrollment at the moment?
"According to clinicaltrials.gov, the trial is actively recruiting patients and was initially posted on October 6th 2022 with a subsequent update noted at the end of November."
Does this experiment accept enrollees of a minimum age of 20?
"The specified range of ages for this medical trial is 18 to 70 years old."
What is the desired outcome of this experiment?
"Regulus Therapeutics Inc., the study's sponsor, has identified biomarker-based ADPKD as the primary outcome and will be measured over a Baseline to Day 113 period. Secondary outcomes pertaining to RGLS8429's pharmacokinetic properties (t½, Cmax) and impact on hight-adjusted total kidney volume (htTKV), respectively, are also being studied."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 1 Day
Most responsive sites:
- National Institute of Clinical Research, Inc.: < 24 hours
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