COMPLETED

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

Conditions

Autosomal Dominant Polycystic Kidney Disease ADPKD Polycystic Kidney, Autosomal Dominant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose and an Open-Label Fixed-Dose Study in Patients With Autosomal Dominant Polycystic Kidney Disease to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RGLS8429

Quick Facts

Study Start:2022-10-06

Study Completion:2025-03-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05521191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 MRI obtained during screening, or a prior MRI obtained within 5 years of screening with documented 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 be willing and able to comply with the protocol	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 procedures and 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 to screening 5. Only one kidney or kidney transplant recipient 6. Participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational 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 the previous study to Day 1 of the current study.

Inclusion Criteria

Exclusion 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 MRI obtained during screening, or a prior MRI obtained within 5 years of screening with documented 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 be willing and able to comply with the protocol

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 procedures and 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 to screening
5. Only one kidney or kidney transplant recipient
6. Participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational 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 the previous study to Day 1 of the current study.

Contacts and Locations

Principal Investigator

Rekha Garg, MD

STUDY_DIRECTOR

Regulus Therapeutics

Study Locations (Sites)

Centricity Research Phoenix Multispecialty

Mesa, Arizona, 85206

United States

Academic Medical Research Institute

Los Angeles, California, 90022

United States

Yale Nephrology Outpatient Clinic

New Haven, Connecticut, 06510

United States

Mayo Clinic - Florida

Jacksonville, Florida, 32224

United States

Elixia

Orlando, Florida, 32806

United States

Southeastern Clinical Research Institute, LLC

Augusta, Georgia, 30904

United States

CARE Institute

Boise, Idaho, 83706

United States

CARE Institute

Chubbuck, Idaho, 83202

United States

The Idaho Kidney Institute

Idaho Falls, Idaho, 83404

United States

University of Chicago

Chicago, Illinois, 60617

United States

Research by Design, LLC

Chicago, Illinois, 60643

United States

University of Iowa

Iowa City, Iowa, 52242

United States

University of Kansas Medical Center Jared Grantham Kidney Institute

Kansas City, Kansas, 66160

United States

Witchita Nephrology Group, PA

Wichita, Kansas, 67214

United States

University of Maryland School of Medicine, Nephrology

Baltimore, Maryland, 21201

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

St. Clair Nephrology Research

Roseville, Michigan, 48066

United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

United States

Northeast Clinical Research Center

Bethlehem, Pennsylvania, 18017

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Swedish Center for Comprehensive Care

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: Regulus Therapeutics Inc.

Rekha Garg, MD, STUDY_DIRECTOR, Regulus Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-06

Study Completion Date2025-03-27

Study Record Updates

Study Start Date2022-10-06

Study Completion Date2025-03-27

Terms related to this study

Additional Relevant MeSH Terms

Autosomal Dominant Polycystic Kidney Disease
ADPKD
Polycystic Kidney, Autosomal Dominant