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

  • Centricity Research
  • Mesa, AZ 85206
  • Contact: Molly Bertel 480-588-7752 [email protected]

California

  • California Institute of Renal Research
  • La Mesa, CA 91942
  • Contact: Yen Vo 619-461-3894 [email protected]
  • Amicis Research Center
  • Granada Hills, CA 91344
  • Contact: Harvey Rosales 818-644-2242 [email protected]
  • Amicis Research Center
  • Beverly Hills, CA 90211
  • Contact: Larissa Arevalo 818-924-4708 [email protected]
  • Academic Medical Research Institute
  • Los Angeles, CA 90022
  • Contact: Kriss Grande 323-725-0051 [email protected]
  • National Institute of Clinical Research, Inc.
  • Garden Grove, CA 92844
  • Contact: Peter Nguyen [email protected]  

Connecticut

  • Yale Nephrology Outpatient Clinic
  • New Haven, CT 06510
  • Contact: Kathryn Simmons 864-525-5134 [email protected]

Florida

Georgia

  • Southeastern Clinical Research Institute
  • Augusta, GA 30904
  • Contact: Matthew Diamond, MD  706-922-3005 [email protected]
  • Contact: Katherine Peacock 706-922-3005 [email protected]

Idaho

  • CARE Institute
  • Chubbuck, ID 83202
  • Contact: Farrah Ishtiaq 208-984-2273 [email protected]
  • The Idaho Kidney Institute
  • Idaho Falls, ID 83404
  • Contact: Jill Heinz, MHS, CCRC, CRCP 208-984-2273 [email protected]

Illinois

  • University of Chicago
  • Chicago, IL 60617
  • Contact: Elizabeth Salvo Brugarolas [email protected]

Iowa

  • University of Iowa
  • Iowa City, IA 52242
  • Contact: Contact: Jissele Verdinez [email protected]

Kansas

  • University of Kansas Medical Center Jared Kidney Institute
  • Kansas City, KS 66160
  • Contact: Cathy Creed 913-588-0053 [email protected]
  • Contact: Elisabeth Laundy 913-588-8983 [email protected]
  • Wichita Nephrology Group, PA
  • Wichita, KS 67214
  • Contact: Michelle Hershberger 316-494-4912 [email protected]

Maryland

  • University of Maryland School of Medicine, Nephrology
  • Baltimore, MD 21201
  • Contact: Charalett Diggs 410-706-2122 [email protected]

Massachusetts

Michigan

  • St. Clair Nephrology Research
  • Roseville, MI 48066
  • Contact: Rosemarie Henschel, RN 313-432-6273 [email protected]

Minnesota

  • Mayo Clinic Rochester
  • Rochester, MN 55905
  • Contact: Cassie Howe 507-266-1230 [email protected]

Nevada

  • Nevada Kidney Disease and Hypertension Centers
  • Las Vegas, NV 89106
  • Contact: Angela Gomez 702-209-7473 [email protected]

Pennsylvania

  • Northeast Clinical Research Center
  • Bethlehem, PA 18107
  • Contact: Sharon Collins 610-433-4100 [email protected]
  • Contact: Nelson Kopyt, MD  610-433-4100

Texas

  • University of Texas Southwestern Medical Center
  • Dallas, TX 75390
  • Contact: Luis Madrigal 214-648-7494 [email protected]

Washington

  • Swedish Medical Center
  • Seattle, WA 98104
  • Contact: Adel Islam 206-215-6532  [email protected]