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Antisense Oligonucleotide

RGLS8429 for Polycystic Kidney Disease

Phase 1
Recruiting
Research Sponsored by Regulus Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female ADPKD patients, 18 to 70 years old
Body mass index (BMI) 18 to 35 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 113
Awards & highlights

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
People with a specific genetic kidney disease, aged 18 to 70.
Select...
Your body mass index (BMI) is between 18 and 35.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 113
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 113 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Polycystic Kidney, Autosomal Dominant
Safety and tolerability of RGLS4829: Incidence of AEs
Secondary outcome measures
Impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
Pharmacokinetic properties of RGLS8429: Cmax
Pharmacokinetic properties of RGLS8429: Tmax
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: RGLS8429Experimental Treatment1 Intervention
The study will consist of three sequential cohorts of 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total). Cohort 1: first dose level of RGLS8429 or placebo Cohort 2: second dose level of RGLS8429 or placebo Cohort 3: third dose level of RGLS8429 or placebo
Group II: PlaceboExperimental Treatment1 Intervention
The study will consist of three sequential cohorts of 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total). Cohort 1: first dose level of RGLS8429 or placebo Cohort 2: second dose level of RGLS8429 or placebo Cohort 3: third dose level of RGLS8429 or placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RGLS8429
2022
Completed Phase 1
~40
Placebo
1995
Completed Phase 3
~2670

Find a Location

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

Media Library

RGLS8429 (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05521191 — Phase 1
Polycystic Kidney Disease Research Study Groups: RGLS8429, Placebo
Polycystic Kidney Disease Clinical Trial 2023: RGLS8429 Highlights & Side Effects. Trial Name: NCT05521191 — Phase 1
RGLS8429 (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05521191 — Phase 1
Polycystic Kidney Disease Patient Testimony for trial: Trial Name: NCT05521191 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Texas
Maine
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
California Institute of Renal Research
Academic Medical Research Institute
Swedish Center for Comprehensive Care
Other
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am young and having early rapid polycystic kidney disease. I’m 32, newly diagnosed and my disease is progressing quickly.
PatientReceived 1 prior treatment
My whole family has ADPKD and my father will likely start dialysis soon and is trying to get on the transplant list.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Average response time
  • < 1 Day
Most responsive sites:
  1. National Institute of Clinical Research, Inc.: < 24 hours
~14 spots leftby Apr 2025