Phase
Condition
Kidney Failure
Treatment
RGLS8429
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male or female ADPKD patients, 18 to 70 years old
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)
eGFR between 30 to 90 mL/min/1.73 m2
Body mass index (BMI) 18 to 35 kg/m2
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:
Administration of tolvaptan in the 28 days before randomization
Subject is mentally incapacitated or has significant emotional problems
Any medical condition or social circumstance that, in the opinion of theInvestigator, may make the subject unlikely to complete the study or comply withstudy procedures and requirements; or may pose a risk to the subject's safety
History or presence of alcoholism or drug abuse within the past 2 years prior toscreening
Only one kidney or kidney transplant recipient
Participation in another clinical trial and/or exposure to any investigational drugor approved 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
Study Description
Connect with a study center
Centricity Research Phoenix Multispecialty
Mesa, Arizona 85206
United StatesSite Not Available
Amicis Research Center
Beverly Hills, California 90211
United StatesSite Not Available
National Institute of Clinical Research, Inc.
Garden Grove, California 92844
United StatesSite Not Available
Amicis Research Center
Granada Hills, California 91344
United StatesSite Not Available
California Institute of Renal Research
La Mesa, California 91942
United StatesSite Not Available
Academic Medical Research Institute
Los Angeles, California 90022
United StatesSite Not Available
Valiance Clinical Research
S. Gate, California 90280
United StatesSite Not Available
Yale Nephrology Outpatient Clinic
New Haven, Connecticut 06510
United StatesSite Not Available
Horizon Research Group, LLC
Coral Gables, Florida 33134
United StatesSite Not Available
Mayo Clinic - Florida
Jacksonville, Florida 32224
United StatesSite Not Available
Elixia
Orlando, Florida 32806
United StatesSite Not Available
Southeastern Clinical Research Institute, LLC
Augusta, Georgia 30904
United StatesSite Not Available
CARE Institute
Boise, Idaho 83706
United StatesSite Not Available
CARE Institute
Chubbuck, Idaho 83202
United StatesSite Not Available
The Idaho Kidney Institute
Idaho Falls, Idaho 83404
United StatesSite Not Available
Boise Kidney and Hypertension, PLLC
Nampa, Idaho 83687
United StatesSite Not Available
Research by Design, LLC
Chicago, Illinois 60643
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60617
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
University of Kansas Medical Center Jared Grantham Kidney Institute
Kansas City, Kansas 66160
United StatesSite Not Available
Witchita Nephrology Group, PA
Wichita, Kansas 67214
United StatesSite Not Available
University of Maryland School of Medicine, Nephrology
Baltimore, Maryland 21201
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
St. Clair Nephrology Research
Roseville, Michigan 48066
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Nevada Kidney Disease and Hypertension Centers
Las Vegas, Nevada 89106
United StatesSite Not Available
Northeast Clinical Research Center
Bethlehem, Pennsylvania 18017
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Swedish Center for Comprehensive Care
Seattle, Washington 98104
United StatesSite Not Available

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