A Study of RGLS8429 in Patients With ADPKD

Multiple Locations

Overview
In this randomized, double-blind, placebo-controlled Phase 1b study, multiple doses of RGLS8429 or placebo will be administered via injection to subjects with ADPKD to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of RGLS8429.

The primary objectives of this trial are to assess the safety, tolerability, and impact of RGLS8429 on ADPKD biomarkers.

Eligibility Criteria

  • Age: 18 to 70 years old
  • eGFR between 30 to 90 mL/min/1.73 m2
  • Body mass index (BMI) 18 to 35 kg/m2
  • 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)

Additional inclusion/exclusion criteria may apply

Participation

Participation will last about 16 weeks (113 days) and will require a subcutaneous injection every other week for 14 weeks (7 doses). Outcome measurements will be taken at baseline and day 113.

Locations
Arizona

California

  • California Institute of Renal Research
  • La Mesa, CA 91942
  • Contact: Yen Vo 619-461-3894 yvo@balboaunited.org
  • Academic Medical Research Institute
  • Los Angeles, CA 90022
  • Contact: Kriss Grande 323-725-0051 kriss@amrionline.net
  • National Institute of Clinical Research, Inc.
  • Garden Grove, CA 92844
  • Contact: Peter Nguyen pnguyen@nicresearch.com  

Connecticut

Florida

Georgia

  • Southeastern Clinical Research Institute
  • Augusta, GA 30904
  • Contact: Matthew Diamond, MD  706-922-3005 mdiamond@nacp.care
  • Contact: Katherine Peacock 706-922-3005 kpeacock@nacp.care

Idaho

Illinois

Iowa

Kansas

  • University of Kansas Medical Center Jared Kidney Institute
  • Kansas City, KS 66160
  • Contact: Cathy Creed 913-588-0053 ccreed@kumc.edu
  • Contact: Elisabeth Laundy 913-588-8983 elaundy@kumc.edu
  • Wichita Nephrology Group, PA
  • Wichita, KS 67214
  • Contact: Michelle Hershberger 316-494-4912 michelle@wngpa.com

Maryland

Massachusetts

Michigan

  • St. Clair Nephrology Research
  • Roseville, MI 48066
  • Contact: Rosemarie Henschel, RN 313-432-6273 rhenschel@scsp.net

Minnesota

Nevada

  • Nevada Kidney Disease and Hypertension Centers
  • Las Vegas, NV 89106
  • Contact: Angela Gomez 702-209-7473 angela.gomez1@freenova.com

Pennsylvania

  • Northeast Clinical Research Center
  • Bethlehem, PA 18107
  • Contact: Sharon Collins 610-433-4100 sharon.collins@necresearch.org
  • Contact: Nelson Kopyt, MD  610-433-4100

Texas

Washington