A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease
Overview
This study involves an investigational drug being developed for the treatment of ADPKD. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (time course of a drug in the body) and pharmacodynamics (relationship between the amount of drug in your body and your response to the drug) of RGLS4326 when administered multiple times via subcutaneous (under the skin) injection.
Each subject will receive RGLS4326 (active drug) administered every 2 weeks over a 6 week time period for a total of 4 doses.
You will not get medical benefit from this study. However, your participation in this study will facilitate the development of a potentially important therapy for ADPKD.
You may be eligible for this study if you:
● Are between 18 to 70 years of age
● Have been diagnosed with ADPKD
● Have a lab value eGFR between 30 to 90 mL/min/1.73 m2
Exclusion Criteria:
● Taking tolvaptan within 28 days prior to the first dose of study drug
● Participation in another interventional study
● Kidney or any other solid organ transplant recipient or a planned transplant during the study
● Women who are pregnant or breastfeeding
The study will last up to approximately 99 days, including a screening period (28 days), treatment period (44 days), and follow-up period (28 days).
Before the study starts, you will be asked to sign consent if you would like to participate. The study doctor or staff will perform assessments and tests including, but not limited to physical examination with simple brain and coordination tests, height and weight, vital signs, electrocardiogram (ECG), which measures your heart’s electrical activity, laboratory blood and urine tests, pregnancy test (if female) and MRI or CT scan to evaluate your ADPKD if you have not had one previously.
You will receive a specified amount in stipend to compensate you for participation in the study and you will also be reimbursed for travel related costs.
There will be 13 total clinical sites located throughout the United States. The locations will be listed here as the sites open up and begin to recruit.
For more information, including how to contact the sites, click the Learn More button at the top of the page. This link will direct you to the ClinTrials.gov website. Once you are directed to this website, please scroll to the very bottom of the page to view the contact information for the site in your area.
California
Balboa Nephrology Medical Group
La Mesa, CA
Academic Medical Research Institute
Los Angeles, CA
Connecticut
Yale Nephrology Clinical Research
New Haven, CT
Kansas
University of Kansas Medical Center
Kansas City, KS
Florida
Mid-Florida Kidney and Hypertension Care
Deland, FL
Massachusetts
Boston, MA
Beth Israel Deaconess Medical Center
Boston, MA
Minnesota
Rochester, MN
Michigan
Roseville, MI
Texas
ICON Early Phase Services
San Antonio, TX
UT Southwestern Medical Center
Dallas, TX
Washington
Seattle, WA