RGLS8429 for Polycystic Kidney Disease

Amicis Research Center, Granada Hills, CA
Polycystic Kidney Disease+1 More ConditionsRGLS8429 - Drug
18 - 70
All Sexes

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.

Eligible Conditions
  • Polycystic Kidney Disease (PKD)
  • Polycystic Kidney Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Baseline to Day 113

Baseline to Day 113
Polycystic Kidney, Autosomal Dominant
Impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
Pharmacokinetic properties of RGLS8429: Cmax
Pharmacokinetic properties of RGLS8429: Tmax
Pharmacokinetic properties of RGLS8429: t½
Safety and tolerability of RGLS4829: Incidence of AEs

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: RGLS8429 · Has Placebo Group · Phase 1

Experimental Group · 1 Intervention: Placebo · Intervention Types: Drug
Experimental Group · 1 Intervention: RGLS8429 · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to day 113

Who is running the clinical trial?

Regulus Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
55 Total Patients Enrolled
Rekha Garg, MDStudy DirectorRegulus Therapeutics
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) between 18 and 35.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
What site did they apply to?
Academic Medical Research Institute100.0%
How many prior treatments have patients received?

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.