A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease, ADPKD, Polycystic Kidney, Autosomal Dominant
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease
Eligibility Criteria
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 MRI obtained during screening, or a prior MRI obtained within 5 years of screening with documented 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 be willing and able to comply with the protocol
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 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
- History or presence of alcoholism or drug abuse within the past 2 years prior to screening
- Only one kidney or kidney transplant recipient
- 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.
Sites / Locations
- Centricity Research Phoenix MultispecialtyRecruiting
- Amicis Research Center
- National Institute of Clinical Research, Inc.Recruiting
- Amicis Research CenterRecruiting
- California Institute of Renal ResearchRecruiting
- Academic Medical Research InstituteRecruiting
- Valiance Clinical Research
- Yale Nephrology Outpatient ClinicRecruiting
- Horizon Research Group, LLC
- Mayo Clinic - FloridaRecruiting
- ElixiaRecruiting
- Southeastern Clinical Research Institute, LLCRecruiting
- CARE InstituteRecruiting
- The Idaho Kidney InstituteRecruiting
- Boise Kidney and Hypertension, PLLCRecruiting
- University of Chicago
- Research by Design, LLCRecruiting
- University of IowaRecruiting
- University of Kansas Medical Center Jared Grantham Kidney InstituteRecruiting
- Witchita Nephrology Group, PARecruiting
- University of Maryland School of Medicine, NephrologyRecruiting
- Tufts Medical Center
- St. Clair Nephrology ResearchRecruiting
- Mayo Clinic - RochesterRecruiting
- Nevada Kidney Disease and Hypertension CentersRecruiting
- Northeast Clinical Research CenterRecruiting
- University of Texas Southwestern Medical CenterRecruiting
- Swedish Center for Comprehensive CareRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
RGLS8429
Placebo
The study will consist of three sequential cohorts of 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total). Cohort 1: first dose level of RGLS8429 or placebo Cohort 2: second dose level of RGLS8429 or placebo Cohort 3: third dose level of RGLS8429 or placebo
The study will consist of three sequential cohorts of 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total). Cohort 1: first dose level of RGLS8429 or placebo Cohort 2: second dose level of RGLS8429 or placebo Cohort 3: third dose level of RGLS8429 or placebo