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 (PKD)
- Polycystic Kidney Disease
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: Baseline to Day 113
Trial Safety
Phase-Based Safety
Trial Design
2 Treatment Groups
Placebo
1 of 2
RGLS8429
1 of 2
Experimental Treatment
36 Total Participants · 2 Treatment Groups
Primary Treatment: RGLS8429 · Has Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Maine | 50.0% |
| Massachusetts | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 50.0% |
| Met criteria | 50.0% |
What site did they apply to?
| Academic Medical Research Institute | 100.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor