Who is sponsoring NCT01215747?

NCT01215747 is sponsored by C.T. Development America, Inc..

What condition does NCT01215747 study?

NCT01215747 studies Amyloidosis.

What drugs are being tested in NCT01215747?

Interventions: KIACTA (eprodisate disodium), Placebo.

What is the status of NCT01215747?

NCT01215747 is currently COMPLETED.

Last reviewed 2016-03-09 · How we verify

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

NCT01215747 Phase 3 COMPLETED

The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.

Details

Lead sponsor	C.T. Development America, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	261
Start date	2010-11
Completion	2016-03

Conditions

Amyloidosis

Interventions

KIACTA (eprodisate disodium)
Placebo

Primary outcomes

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

Countries

United States, Belgium, Egypt, Estonia, Finland, France, Georgia, Germany, India, Israel, Italy, Latvia, Lithuania, Netherlands, Peru, Poland, Russia, Spain, Sweden, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom