International Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of KIACTA in Preventing Renal Function Decline in Patients With AA Amyloidosis
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Time from baseline to a persistent decrease in Creatinine clearance (CrCL) of 40% or more, a persistent increase in Serum Creatinine(SCr) of 80% or more, or progression to end-stage renal disease(ESRD)
Up to 24 months
No
Tomasz Sablinski, MD, PhD
Study Director
CT Development America, Inc.
United States: Food and Drug Administration
CL-503012
NCT01215747
November 2010
May 2014
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Stanford University | Stanford, California 94305 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Boston Medical Center | Boston, Massachusetts 02118 |
Ohio State University Medical Center | Columbus, Ohio 43210 |
Indiana University | Indianapolis, Indiana 46202 |
Barbara Ann Karmanos Cancer Center | Detroit, Michigan 48201 |
National Institute of Arthritis and Musculoskeletal and Skin Diseases | Bethesda, Maryland 20892-1662 |
Raffi Minasian MD a Medical Corporation | Glendale, California 91204 |