Efficacy and Safety of Lixivaptan in the Treatment of ADPKD (ACTION)
The ACTION Study is a Phase 3 clinical trial designed to examine the safety and efficacy of the study drug, lixivaptan, compared with placebo (sugar pill) in patients with ADPKD. Part 1 of the trial will aim to demonstrate the efficacy of lixivaptan in slowing the decline in renal function as measured by the difference in estimated glomerular filtration rate (eGFR) and the change in total kidney volume (size) between the lixivaptan-treated and placebo-treated participants. Part 2 of the study will hopefully provide confirmation of the durability of this effect during which all subjects will receive lixivaptan. Additionally, both parts of the study will contribute to understanding the safety of lixivaptan, particularly any effects on liver chemistry tests.
Enrolled participants will be asked to come to the clinic multiple times over approximately 131 weeks (about 2.5 years) for lab work (blood collection) and imaging (MRI to measure total kidney and liver volumes).
You may be able to participate if you:
- Are between the ages 18-60 at the time of screening
- Have a confirmed diagnosis of ADPKD by imaging or genetic (DNA) analysis
- Have an eGFR between 25-90 mL/min/1.73 m2
- Have a body mass index (BMI) between 18 and 40 kg/m2
- Are not taking tolvaptan
- Are not pregnant or breastfeeding
Other eligibility criteria will apply
Study drug and assessments will be provided at no cost. Reimbursements for reasonable study related expenses, may be provided.
Pennsylvania Northeast Clinical Research Center
LLC Bethlehem, PA 18107
Clinical Research Consultants, LLC
Kansas City, MO 64111
Knoxville Kidney Center (KKC), PLLC
.Knoxville, TN 37923
Oscar G. Galvez, MD PA
Hialeah, FL 33010