A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease

Last updated: April 27, 2024
Sponsor: Regulus Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Kidney Failure

Treatment

RGLS8429

Placebo

Clinical Study ID

NCT05521191
RGLS8429-02
  • Ages 18-70
  • All Genders

Study Summary

Primary Objectives

  • To assess the safety and tolerability of RGLS8429

  • To assess the impact of RGLS8429 on ADPKD biomarkers

Secondary Objectives

  • To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)

  • To characterize the pharmacokinetic (PK) properties of RGLS8429

  • To assess the impact of RGLS8429 on renal function

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Male or female ADPKD patients, 18 to 70 years old
  2. Class 1C, 1D, or 1E Mayo Imaging Classification of ADPKD (based upon either the MRIobtained during screening, or a prior MRI obtained within 5 years of screening withdocumented Mayo classification)
  3. eGFR between 30 to 90 mL/min/1.73 m2
  4. Body mass index (BMI) 18 to 35 kg/m2
  5. Must understand and consent to the study procedures explained in the ICF and bewilling and able to comply with the protocol

Exclusion

Key Exclusion Criteria:

  1. Administration of tolvaptan in the 28 days before randomization
  2. Subject is mentally incapacitated or has significant emotional problems
  3. Any medical condition or social circumstance that, in the opinion of the Investigator,may make the subject unlikely to complete the study or comply with study proceduresand requirements; or may pose a risk to the subject's safety
  4. History or presence of alcoholism or drug abuse within the past 2 years prior toscreening
  5. Only one kidney or kidney transplant recipient
  6. Participation in another clinical trial and/or exposure to any investigational drug orapproved therapy for investigational use within 28 days or 5 half-lives of theinvestigational drug's dosing, whichever is longer, prior to dosing. The 28-day or 5-half-life windows will be calculated from the date of the last dosing in theprevious study to Day 1 of the current study.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: RGLS8429
Phase: 1
Study Start date:
October 06, 2022
Estimated Completion Date:
June 30, 2025

Study Description

This is a randomized, double-blind, placebo-controlled multiple ascending dose and an open-label fixed-dose Phase 1b study consisting of two parts, Part A and Part B. In Part A, multiple ascending doses of RGLS8429 or placebo will be administered via subcutaneous injection to subjects with ADPKD to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of RGLS8429. In Part B, a fixed-dose of RGLS8429 will be administered via subcutaneous injection to subjects with ADPKD to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of RGLS8429.

Connect with a study center

  • Centricity Research Phoenix Multispecialty

    Mesa, Arizona 85206
    United States

    Terminated

  • Amicis Research Center

    Beverly Hills, California 90211
    United States

    Site Not Available

  • National Institute of Clinical Research, Inc.

    Garden Grove, California 92844
    United States

    Site Not Available

  • Amicis Research Center

    Granada Hills, California 91344
    United States

    Site Not Available

  • California Institute of Renal Research

    La Mesa, California 91942
    United States

    Site Not Available

  • Academic Medical Research Institute

    Los Angeles, California 90022
    United States

    Active - Recruiting

  • Valiance Clinical Research

    S. Gate, California 90280
    United States

    Site Not Available

  • Yale Nephrology Outpatient Clinic

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Horizon Research Group, LLC

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Mayo Clinic - Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Elixia

    Orlando, Florida 32806
    United States

    Completed

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia 30904
    United States

    Active - Recruiting

  • CARE Institute

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • CARE Institute

    Chubbuck, Idaho 83202
    United States

    Active - Recruiting

  • The Idaho Kidney Institute

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Boise Kidney and Hypertension, PLLC

    Nampa, Idaho 83687
    United States

    Site Not Available

  • Research by Design, LLC

    Chicago, Illinois 60643
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60617
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kansas Medical Center Jared Grantham Kidney Institute

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Witchita Nephrology Group, PA

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • University of Maryland School of Medicine, Nephrology

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • St. Clair Nephrology Research

    Roseville, Michigan 48066
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Nevada Kidney Disease and Hypertension Centers

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Northeast Clinical Research Center

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Swedish Center for Comprehensive Care

    Seattle, Washington 98104
    United States

    Active - Recruiting

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